ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road Athens, Texas 75751 USA
Tel: 800-927-4669;
Tel: +1 903-675-9321
www.argonmedical.com
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Atrieve™ Vascular Snare Kit
Atrieve™ Vascular Snare Kit
Indication for Use:
Indication for Use:
Indication for Use:
The Atrieve™ Vascular Snare Kit is intended for use in the cardiovascular system or hollow viscous
The Atrieve™ Vascular Snare Kit is intended for use in the cardiovascular system or hollow viscous
The Atrieve™ Vascular Snare Kit is intended for use in the cardiovascular system or hollow viscous to
to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous
to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous
catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access
catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access
retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter
veni-puncture procedure assistance.
veni-puncture procedure assistance.
repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-
puncture procedure assistance.
Description:
Description:
The Atrieve™ Vascular Snare Kit comprises a Snare device with three preformed loops constructed of
The Atrieve™ Vascular Snare Kit comprises a Snare device with three preformed loops constructed of
Description:
super-elastic nitinol and platinum. The loops are non-interwoven and can slide relative to one another.
super-elastic nitinol and platinum. The loops are non-interwoven and can slide relative to one another.
The Atrieve™ Vascular Snare Kit comprises a Snare device with three preformed loops constructed of
The loops of the Snare can be introduced into a delivery catheter without the risk of permanent device
The loops of the Snare can be introduced into a delivery catheter without the risk of permanent device
super-elastic nitinol and platinum. The loops are non-interwoven and can slide relative to one another.
deformation. The Atrieve™ Vascular Snare Kit also includes a Delivery Catheter, a torque handle, and
deformation. The Atrieve™ Vascular Snare Kit also includes a Delivery Catheter, a torque handle, and
The loops of the Snare can be introduced into a delivery catheter without the risk of permanent device
an Introducer. The Delivery Catheter has a radiopaque marker band at the distal tip. The product comes
an Introducer. The Delivery Catheter has a radiopaque marker band at the distal tip. The product comes
deformation. The Atrieve™ Vascular Snare Kit also includes a Delivery Catheter, a torque handle, and
packaged in a protective hoop holder.
packaged in a protective hoop holder.
an Introducer. The Delivery Catheter has a radiopaque marker band at the distal tip. The product comes
The Atrieve™ Vascular Snare Kit is available in the following sizes:
The Atrieve™ Vascular Snare Kit is available in the following sizes:
packaged in a protective hoop holder.
Snare
Snare
Diameter Range
Diameter Range
The Atrieve™ Vascular Snare Kit is available in the following sizes:
2-4 mm
2-4 mm
4-8 mm
4-8 mm
Snare Diameter
6-10 mm
6-10 mm
Range
9-15 mm
Snare Length
9-15 mm
Size
12-20 mm
12-20 mm
2-4 mm
175 cm
3.2 F
18-30 mm
18-30 mm
27-45 mm
27-45 mm
4-8 mm
175 cm
3.2 F
6-10 mm
120 cm
6 F
Warnings:
Warnings:
1.
This device is not intended for the removal of foreign objects entrapped by tissue growth.
1.
This device is not intended for the removal of foreign objects entrapped by tissue growth.
9-15 mm
120 cm
6 F
2.
This device should not be used for fibrin sheath stripping in the presence of septal defects of
2.
This device should not be used for fibrin sheath stripping in the presence of septal defects of
12-20 mm
120 cm
6 F
Persistent Foramen Ovale.
Persistent Foramen Ovale.
3.
This device is not intended for removal of implanted pacing leads.
3.
This device is not intended for removal of implanted pacing leads.
18-30 mm
120 cm
7 F
4.
Pull forces applied to catheters during fibrin sheath stripping may damage, stretch, or break
4.
Pull forces applied to catheters during fibrin sheath stripping may damage, stretch, or break
27-45 mm
120 cm
7 F
indwelling catheters 6 French or smaller in diameter. Do not use excessive pull force when
indwelling catheters 6 French or smaller in diameter. Do not use excessive pull force when
attempting fibrin sheath stripping of catheters 6 French or smaller in diameter.
attempting fibrin sheath stripping of catheters 6 French or smaller in diameter.
5.
Do not use excessive force when manipulating the catheter through an introducer. Excessive
5.
Do not use excessive force when manipulating the catheter through an introducer. Excessive
Warnings:
force may damage the catheter.
force may damage the catheter.
1.
This device is not intended for the removal of foreign objects entrapped by tissue growth.
6.
This device was designed, tested and manufactured for single patient use only. Reuse or
6.
This device was designed, tested and manufactured for single patient use only. Reuse or
2.
This device should not be used for fibrin sheath stripping in the presence of septal defects of
reprocessing of this device may lead to its failure and subsequent patient injury. Reprocessing
reprocessing of this device may lead to its failure and subsequent patient injury. Reprocessing
Persistent Foramen Ovale.
and/or resterilization of this device may create the risk of contamination and patient infection.
and/or resterilization of this device may create the risk of contamination and patient infection.
3.
This device is not intended for removal of implanted pacing leads.
Do not reuse, reprocess or resterilize this device.
Do not reuse, reprocess or resterilize this device.
4.
Pull forces applied to catheters during fibrin sheath stripping may damage, stretch, or break
7.
Nitinol is a nickel titanium alloy. Possible reaction may occur for those patients who exhibit
7.
Nitinol is a nickel titanium alloy. Possible reaction may occur for those patients who exhibit
indwelling catheters 6 French or smaller in diameter. Do not use excessive pull force when attempt-
sensitivity to nickel.
sensitivity to nickel.
ing fibrin sheath stripping of catheters 6 French or smaller in diameter.
8.
Possible reaction may occur for those patients who exibit sensitivity to platinum.
8.
Possible reaction may occur for those patients who exibit sensitivity to platinum.
5.
Do not use excessive force when manipulating the catheter through an introducer. Excessive force
Precaution:
Precaution:
may damage the catheter.
1. Care should be observed when using this device for removal of a large fibrin sheath in order to
1. Care should be observed when using this device for removal of a large fibrin sheath in order to
6.
This device was designed, tested and manufactured for single patient use only. Reuse or repro-
minimize risk of pulmonary embolism.
minimize risk of pulmonary embolism.
cessing of this device may lead to its failure and subsequent patient injury. Reprocessing and/
2. Bleeding may occur through the delivery catheter hub during some procedures. A hemostasis
2. Bleeding may occur through the delivery catheter hub during some procedures. A hemostasis
or resterilization of this device may create the risk of contamination and patient infection. Do not
valve (not included) can be attached to the delivery catheter to reduce the bleeding as needed or
valve (not included) can be attached to the delivery catheter to reduce the bleeding as needed or
reuse, reprocess or resterilize this device.
per physician's judgment.
per physician's judgment.
7.
Nitinol is a nickel titanium alloy. Possible reaction may occur for those patients who exhibit sensitiv-
ity to nickel.
Potential Complications:
Potential Complications:
8.
Possible reaction may occur for those patients who exibit sensitivity to platinum.
1.
Potential complications associated with foreign body retrieval devices in arterial vasculature
1.
Potential complications associated with foreign body retrieval devices in arterial vasculature
include, but are not limited to:
include, but are not limited to:
Embolization
Precaution:
Stroke
1.
Care should be observed when using this device for removal of a large fibrin sheath in order to
Myocardial infarction (depending upon placement)
minimize risk of pulmonary embolism.
2.
Potential complications associated with foreign body retrieval devices in venous vasculature
2.
Potential complications associated with foreign body retrieval devices in venous vasculature
2.
Bleeding may occur through the delivery catheter hub during some procedures. A hemostasis valve
include, but are not limited to:
include, but are not limited to:
(not included) can be attached to the delivery catheter to reduce the bleeding as needed or per
Pulmonary embolism
physician's judgment.
3.
Other potential complications associated with foreign body retrieval devices include, but are
3.
Other potential complications associated with foreign body retrieval devices include, but are
not limited to:
not limited to:
Potential Complications:
Vessel perforation
Device entrapment
1.
Potential complications associated with foreign body retrieval devices in arterial vasculature
Catheter damage can occur when attempting fibrin sheath stripping on small French size diameter
Catheter damage can occur when attempting fibrin sheath stripping on small French size diameter
include, but are not limited to:
catheters (See WARNINGS). Incidence of pulmonary embolism after fibrin sheath stripping may
catheters (See WARNINGS). Incidence of pulmonary embolism after fibrin sheath stripping may
Embolization
Ø
occur (See PRECAUTION).
occur (See PRECAUTION).
Stroke
Ø
Myocardial infarction (depending upon placement)
Ø
Prepare the Snare:
Prepare the Snare:
2.
Potential complications associated with foreign body retrieval devices in venous vasculature
Select the appropriate Snare diameter range for the site in which the foreign body is located. The
Select the appropriate Snare diameter range for the site in which the foreign body is located. The
include, but are not limited to:
Snare diameter range should approximate the size of the vessel in which it will be used.
Snare diameter range should approximate the size of the vessel in which it will be used.
Pulmonary embolism
1.
Remove the Snare and Delivery Catheter components of the kit from their hoop holders and
1.
Remove the Snare and Delivery Catheter components of the kit from their hoop holders and
Ø
inspect for any damage.
inspect for any damage.
3.
Other potential complications associated with foreign body retrieval devices include, but are not
2.
Remove the Introducer and Torque Handle device from the proximal end of the Snare shaft.
2.
Remove the Introducer and Torque Handle device from the proximal end of the Snare shaft.
limited to:
3.
Load the Snare into the Delivery Catheter by inserting the proximal end of the Snare into the
3.
Load the Snare into the Delivery Catheter by inserting the proximal end of the Snare into the
Vessel perforation
Ø
distal (non-hubbed) end of the Delivery Catheter, until the proximal end of the Snare shaft
distal (non-hubbed) end of the Delivery Catheter, until the proximal end of the Snare shaft
Device entrapment
Ø
exits the hub and the loops can be retracted into the distal end of the Delivery Catheter.
exits the hub and the loops can be retracted into the distal end of the Delivery Catheter.
Catheter damage can occur when attempting fibrin sheath stripping on small French size diameter
4.
Test and inspect the Snare device by extending and retracting the loops through the distal end
4.
Test and inspect the Snare device by extending and retracting the loops through the distal end
catheters (See WARNINGS). Incidence of pulmonary embolism after fibrin sheath stripping may occur
of the Catheter 2-3 times, while carefully examining the Delivery Catheter, radiopaque band
of the Catheter 2-3 times, while carefully examining the Delivery Catheter, radiopaque band
(See PRECAUTION).
and the device for any damage or defects.
and the device for any damage or defects.
5.
When appropriate, the Snare and Catheter can be advanced to the desired site as a single
5.
When appropriate, the Snare and Catheter can be advanced to the desired site as a single
Prepare the Snare:
unit assembled as described above.
unit assembled as described above.
Select the appropriate Snare diameter range for the site in which the foreign body is located. The Snare
diameter range should approximate the size of the vessel in which it will be used.
1.
Remove the Snare and Delivery Catheter components of the kit from their hoop holders and
inspect for any damage.
2.
Remove the Introducer and Torque Handle device from the proximal end of the Snare shaft.
3.
Load the Snare into the Delivery Catheter by inserting the proximal end of the Snare into the distal
(non-hubbed) end of the Delivery Catheter, until the proximal end of the Snare shaft exits the hub
and the loops can be retracted into the distal end of the Delivery Catheter.
ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road Athens, Texas 75751 USA
Tel: 800-927-4669;
Tel: +1 903-675-9321
www.argonmedical.com
Atrieve™ Vascular Snare Kit
Snare
Delivery Catheter
Snare
Delivery Catheter
Length
Size
Length
Length
Size
175 cm
3.2 F
175 cm
150 cm
3.2 F
175 cm
3.2 F
175 cm
150 cm
3.2 F
Delivery Catheter
120 cm
6 F
120 cm
100 cm
6 F
120 cm
Length
6 F
120 cm
100 cm
6 F
120 cm
6 F
120 cm
100 cm
6 F
150 cm
120 cm
7 F
120 cm
100 cm
7 F
120 cm
7 F
120 cm
100 cm
7 F
150 cm
100 cm
100 cm
100 cm
100 cm
100 cm
Embolization
Stroke
Myocardial infarction (depending upon placement)
Pulmonary embolism
Vessel perforation
Device entrapment
Alternative Preparation of the Snare
If the Delivery Catheter is already positioned within the vasculature, the provided
4.
Test and inspect the Snare device by extending and retracting the loops through the distal end of
Introducer (located on the proximal end of the Snare and just distal to the Torque Handle) may
the Catheter 2-3 times, while carefully examining the Delivery Catheter, radiopaque band and the
be used to position the Snare in the indwelling Delivery Catheter.
device for any damage or defects.
1.
Remove the Snare from the hoop holder and inspect for any damage.
2.
Move the provided Introducer (located on the proximal end of the Snare, just distal to the
5.
When appropriate, the Snare and Catheter can be advanced to the desired site as a single unit
Torque Handle) distally until the loops of the Snare are enclosed within the tubing portion of
assembled as described above.
the Introducer.
3.
Insert the distal end of the Introducer into the hub of the indwelling Delivery Catheter until
Alternative Preparation of the Snare
resistance is felt. This will indicate the tip of the Introducer is properly aligned with the inner
If the Delivery Catheter is already positioned within the vasculature, the provided
lumen.
Introducer (located on the proximal end of the Snare and just distal to the Torque Handle) may be used
4.
Hold the Introducer as straight as possible, grasp the shaft of the Snare just proximal to the
to position the Snare in the indwelling Delivery Catheter.
hub of the Introducer and advance the Snare until it is secure within the lumen of the
1.
Remove the Snare from the hoop holder and inspect for any damage.
Delivery Catheter. The Introducer can be removed by first removing the Torque Handle and
2.
Move the provided Introducer (located on the proximal end of the Snare, just distal to the Torque
pulling the Introducer off the proximal end of the Snare's shaft. After removing the
Handle) distally until the loops of the Snare are enclosed within the tubing portion of the Introducer.
Introducer, re-apply the Torque Handle onto the shaft.
3.
Insert the distal end of the Introducer into the hub of the indwelling Delivery Catheter until resist-
Snare Assisted Retrieval and Manipulation Suggestions:
ance is felt. This will indicate the tip of the Introducer is properly aligned with the inner lumen.
1.
If present, remove the indwelling delivery catheter.
4.
Hold the Introducer as straight as possible, grasp the shaft of the Snare just proximal to the hub of the
2.
If a guidewire is in a patient at the location of a foreign body, advance the Delivery Catheter
Introducer and advance the Snare until it is secure within the lumen of the Delivery Catheter. The Intro-
over the guidewire to the desired location. Then remove the guidewire and advance the
ducer can be removed by first removing the Torque Handle and pulling the Introducer off the proximal
Snare through the Delivery Catheter. Alternatively, cinch one loop of the Snare over the
end of the Snare's shaft. After removing the Introducer, re-apply the Torque Handle onto the shaft.
proximal end of the guidewire and advance the Snare and Catheter assembly into a guide
Length
catheter or introducer sheath until the distal end of the Delivery Catheter is positioned
150 cm
Snare Assisted Retrieval and Manipulation Suggestions:
proximal to the foreign body.
150 cm
3.
If a guidewire is not present, pull the Snare into the distal end of the Delivery Catheter and
1.
If present, remove the indwelling delivery catheter.
100 cm
advance through a guide catheter or introducer sheath (not included) until it is positioned
2.
If a guidewire is in a patient at the location of a foreign body, advance the Delivery Catheter over
100 cm
proximal to the foreign body. Alternatively, collapse the Snare loops by pulling the device
100 cm
the guidewire to the desired location. Then remove the guidewire and advance the Snare through
into the distal end of the Introducer. Place the tapered end of the Introducer into the
100 cm
the Delivery Catheter. Alternatively, cinch one loop of the Snare over the proximal end of the guide-
proximal (hub) end of the Delivery Catheter, guide catheter or sheath and advance the
100 cm
wire and advance the Snare and Catheter assembly into a guide catheter or introducer sheath until
Snare forward maintaining constant contact between the Introducer and Delivery Catheter
the distal end of the Delivery Catheter is positioned proximal to the foreign body.
hub.
3.
If a guidewire is not present, pull the Snare into the distal end of the Delivery Catheter and advance
NOTE: When attempting to utilize guide catheters or sheaths not specifically manufactured
through a guide catheter or introducer sheath (not included) until it is positioned proximal to the
for use with the Atrieve™ Vascular Snare, it is important to test product compatibility prior to
foreign body. Alternatively, collapse the Snare loops by pulling the device into the distal end of
use.
4.
Gently push the Snare shaft forward to completely open the loops outside of the Delivery
the Introducer. Place the tapered end of the Introducer into the proximal (hub) end of the Delivery
Catheter. The loops are then slowly advanced forward, and may be rotated if desired,
Catheter, guide catheter or sheath and advance the Snare forward maintaining constant contact
around the proximal end of the foreign body. Alternatively, the Snare may be advanced
between the Introducer and Delivery Catheter hub.
beyond the target location and the loops brought back around the distal end of the foreign
NOTE: When attempting to utilize guide catheters or sheaths not specifically manufactured for use
body.
with the Atrieve™ Vascular Snare, it is important to test product compatibility prior to use.
5.
By advancing the Delivery Catheter, the loops of the device are closed to capture the
4.
Gently push the Snare shaft forward to completely open the loops outside of the Delivery Catheter.
foreign body. (Note that attempting to close the loops by pulling the Snare into the Delivery
The loops are then slowly advanced forward, and may be rotated if desired, around the proximal
Catheter will move the loops from their position around the foreign body.)
end of the foreign body. Alternatively, the Snare may be advanced beyond the target location and
6.
To manipulate a foreign body, maintain tension on the Delivery Catheter to retain the hold
the loops brought back around the distal end of the foreign body.
on the foreign body, and move the Snare and Delivery Catheter together to manipulate a
foreign body to the desired position.
5.
By advancing the Delivery Catheter, the loops of the device are closed to capture the foreign body.
7.
To retrieve a foreign body, maintain tension on the Delivery Catheter and move the Snare
(Note that attempting to close the loops by pulling the Snare into the Delivery Catheter will move
and Delivery Catheter assembly together proximally to, or into a guide catheter or sheath.
the loops from their position around the foreign body.)
The foreign body is then withdrawn through or together with the guiding catheter or
6.
To manipulate a foreign body, maintain tension on the Delivery Catheter to retain the hold on the
introducer sheath. Withdrawal of large foreign bodies may require the insertion of larger
foreign body, and move the Snare and Delivery Catheter together to manipulate a foreign body to
sheaths, guiding catheters, or a cut-down at the peripheral site.
the desired position.
7.
To retrieve a foreign body, maintain tension on the Delivery Catheter and move the Snare and
Snare Assisted Removal of Fibrin Sheaths from Indwelling Catheters:
1.
Delivery Catheter assembly together proximally to, or into a guide catheter or sheath. The foreign
Using standard technique, prepare a femoral vein approach, advance the selected Snare to
the inferior vena cava or right atrium.
body is then withdrawn through or together with the guiding catheter or introducer sheath. With-
2.
Advance a 0.035" guidewire through the end port (distal or venous port if more than one
drawal of large foreign bodies may require the insertion of larger sheaths, guiding catheters, or a
lumen) of the indwelling catheter and into the inferior vena cava or right atrium.
cut-down at the peripheral site.
3.
Position one of the Snare loops around the guidewire.
4.
Advance the Snare over the distal end of the indwelling catheter to a position proximal to
Snare Assisted Removal of Fibrin Sheaths from Indwelling Catheters:
the fibrin sheath.
1.
Using standard technique, prepare a femoral vein approach, advance the selected Snare to the
5.
Close the Snare around the indwelling catheter and continue applying light traction while
inferior vena cava or right atrium.
gently pulling the Snare down toward the distal end of the indwelling catheter over the end
2.
Advance a 0.035" guidewire through the end port (distal or venous port if more than one lumen) of
ports.
6.
the indwelling catheter and into the inferior vena cava or right atrium.
Repeat steps 4 & 5 until the indwelling catheter is free of fibrin sheath.
3.
Position one of the Snare loops around the guidewire.
Snare Assisted Venous Canalization:
4.
Advance the Snare over the distal end of the indwelling catheter to a position proximal to the fibrin
1.
Introduce the Snare at a patent venous access site and position in the vasculature at the
sheath.
desired site.
5.
Close the Snare around the indwelling catheter and continue applying light traction while gently
2.
Open the Snare loops to provide a target to guide an entry needle into the desired venous
pulling the Snare down toward the distal end of the indwelling catheter over the end ports.
access site.
6.
Repeat steps 4 & 5 until the indwelling catheter is free of fibrin sheath.
3.
Introduce a guidewire through the needle and through the Snare loops. Remove the needle.
4.
Close the Snare over the guidewire by advancing the Delivery Catheter.
Snare Assisted Venous Canalization:
5.
Pull the guidewire into the desired location.
1.
Introduce the Snare at a patent venous access site and position in the vasculature at the desired
How Supplied
site.
The Atrieve™ Vascular Snare Kit is sterilized by ethylene oxide gas. Content is sterile and non-
2.
Open the Snare loops to provide a target to guide an entry needle into the desired venous access
pyrogenic in unopened and undamaged package. Do not use device if package has been
site.
damaged or has been opened.
3.
Introduce a guidewire through the needle and through the Snare loops. Remove the needle.
4.
Close the Snare over the guidewire by advancing the Delivery Catheter.
Storage
5.
Store in a cool, dry place.
Pull the guidewire into the desired location.
Disposal
How Supplied
After use the Atrieve™ Vascular Snare Kit may be potential biohazard. Handle and dispose of in
The Atrieve™ Vascular Snare Kit is sterilized by ethylene oxide gas. Content is sterile and non-
accordance with accepted medical practice and all applicable laws and regulations.
pyrogenic in unopened and undamaged package. Do not use device if package has been damaged or
has been opened.
Atrieve
TM
Vascular Snare is a trademark of Argon Medical Devices, Inc.
©2013 Argon Medical Devices, Inc.. All rights reserved.
Storage
Store in a cool, dry place.
1
1
Disposal
After use the Atrieve™ Vascular Snare Kit may be potential biohazard. Handle and dispose of in
accordance with accepted medical practice and all applicable laws and regulations.
Atrieve Vascular Snare is a trademark of Argon Medical Devices, Inc.
©2013 Argon Medical Devices, Inc.. All rights reserved.
1
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The Netherlands
Alternative Preparation of the Snare
If the Delivery Catheter is already positioned within the vasculature, the provided
Introducer (located on the proximal end of the Snare and just distal to the Torque Handle) may
be used to position the Snare in the indwelling Delivery Catheter.
1.
Remove the Snare from the hoop holder and inspect for any damage.
2.
Move the provided Introducer (located on the proximal end of the Snare, just distal to the
Torque Handle) distally until the loops of the Snare are enclosed within the tubing portion of
the Introducer.
3.
Insert the distal end of the Introducer into the hub of the indwelling Delivery Catheter until
resistance is felt. This will indicate the tip of the Introducer is properly aligned with the inner
lumen.
4.
Hold the Introducer as straight as possible, grasp the shaft of the Snare just proximal to the
hub of the Introducer and advance the Snare until it is secure within the lumen of the
Delivery Catheter. The Introducer can be removed by first removing the Torque Handle and
pulling the Introducer off the proximal end of the Snare's shaft. After removing the
Introducer, re-apply the Torque Handle onto the shaft.
Snare Assisted Retrieval and Manipulation Suggestions:
1.
If present, remove the indwelling delivery catheter.
2.
If a guidewire is in a patient at the location of a foreign body, advance the Delivery Catheter
over the guidewire to the desired location. Then remove the guidewire and advance the
Snare through the Delivery Catheter. Alternatively, cinch one loop of the Snare over the
proximal end of the guidewire and advance the Snare and Catheter assembly into a guide
catheter or introducer sheath until the distal end of the Delivery Catheter is positioned
proximal to the foreign body.
3.
If a guidewire is not present, pull the Snare into the distal end of the Delivery Catheter and
advance through a guide catheter or introducer sheath (not included) until it is positioned
proximal to the foreign body. Alternatively, collapse the Snare loops by pulling the device
into the distal end of the Introducer. Place the tapered end of the Introducer into the
proximal (hub) end of the Delivery Catheter, guide catheter or sheath and advance the
Snare forward maintaining constant contact between the Introducer and Delivery Catheter
hub.
NOTE: When attempting to utilize guide catheters or sheaths not specifically manufactured
for use with the Atrieve™ Vascular Snare, it is important to test product compatibility prior to
use.
4.
Gently push the Snare shaft forward to completely open the loops outside of the Delivery
Catheter. The loops are then slowly advanced forward, and may be rotated if desired,
around the proximal end of the foreign body. Alternatively, the Snare may be advanced
beyond the target location and the loops brought back around the distal end of the foreign
body.
5.
By advancing the Delivery Catheter, the loops of the device are closed to capture the
foreign body. (Note that attempting to close the loops by pulling the Snare into the Delivery
Catheter will move the loops from their position around the foreign body.)
6.
To manipulate a foreign body, maintain tension on the Delivery Catheter to retain the hold
on the foreign body, and move the Snare and Delivery Catheter together to manipulate a
foreign body to the desired position.
7.
To retrieve a foreign body, maintain tension on the Delivery Catheter and move the Snare
and Delivery Catheter assembly together proximally to, or into a guide catheter or sheath.
The foreign body is then withdrawn through or together with the guiding catheter or
introducer sheath. Withdrawal of large foreign bodies may require the insertion of larger
sheaths, guiding catheters, or a cut-down at the peripheral site.
Snare Assisted Removal of Fibrin Sheaths from Indwelling Catheters:
1.
Using standard technique, prepare a femoral vein approach, advance the selected Snare to
the inferior vena cava or right atrium.
2.
Advance a 0.035" guidewire through the end port (distal or venous port if more than one
lumen) of the indwelling catheter and into the inferior vena cava or right atrium.
3.
Position one of the Snare loops around the guidewire.
4.
Advance the Snare over the distal end of the indwelling catheter to a position proximal to
the fibrin sheath.
5.
Close the Snare around the indwelling catheter and continue applying light traction while
gently pulling the Snare down toward the distal end of the indwelling catheter over the end
ports.
6.
Repeat steps 4 & 5 until the indwelling catheter is free of fibrin sheath.
Snare Assisted Venous Canalization:
1.
Introduce the Snare at a patent venous access site and position in the vasculature at the
desired site.
2.
Open the Snare loops to provide a target to guide an entry needle into the desired venous
access site.
3.
Introduce a guidewire through the needle and through the Snare loops. Remove the needle.
4.
Close the Snare over the guidewire by advancing the Delivery Catheter.
5.
Pull the guidewire into the desired location.
How Supplied
The Atrieve™ Vascular Snare Kit is sterilized by ethylene oxide gas. Content is sterile and non-
pyrogenic in unopened and undamaged package. Do not use device if package has been
damaged or has been opened.
Storage
Store in a cool, dry place.
Disposal
After use the Atrieve™ Vascular Snare Kit may be potential biohazard. Handle and dispose of in
accordance with accepted medical practice and all applicable laws and regulations.
Atrieve
TM
Vascular Snare is a trademark of Argon Medical Devices, Inc.
©2013 Argon Medical Devices, Inc.. All rights reserved.
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