Bard Atlas Gold PTA Dilatation Catheter Instructions For Use Manual

PTA Dilatation Catheter
ENGLISH
INSTRUCTIONS FOR USE
CAUTION: Federal (U.S.A.) law restricts this device to
sale by or on the order of a physician.
Device Description
®
The Atlas gold PTA Dilatation Catheter is a high
performance balloon catheter consisting of an over-the-
wire catheter with a balloon fixed at the distal tip. The
proprietary non-compliant, low profile balloon is designed
to provide consistent balloon diameters and lengths even
at high pressures. Two radiopaque markers delineate
the working length of the balloon and aid in balloon
placement. The coaxial catheter includes a tapered
atraumatic tip to facilitate advancement of the catheter
to and through the stenosis. The proximal portion of the
catheter includes a female luer lock hub connected to the
inflation lumen, and a female luer-lock hub connected
to the guidewire lumen. The over-the-wire catheter is
compatible with .035" guidewire and is available in 80cm
and 120cm working lengths.
Packaged with every product is a profile reducing sheath
that is positioned over the balloon for protection before
use. A re-wrapping tool is also provided on the catheter
shaft to aid in re-wrap/refolding of the balloon.
This product is not manufactured with any natural rubber
latex.
Indications for Use
®
Atlas gold PTA Dilatation Catheter is indicated for use in
Percutaneous Transluminal Angioplasty of the peripheral
vasculature, including the iliac arteries and iliac and
femoral veins, and for the treatment of obstructive lesions
of native or synthetic arteriovenous dialysis fistulae. This
device is also indicated for post-dilatation of stents and
stent grafts in the peripheral vasculature. This catheter is
not for use in coronary arteries.
Contraindications
None known.
Warnings
1. Contents supplied STERILE using ethylene oxide
(EO). Non-Pyrogenic. Do not use if sterile barrier
is opened or damaged. Single patient use only. Do
not reuse, reprocess, or re-sterilize.
2. This device has been designed for single use
only. Reusing this medical device bears the risk
of cross-patient contamination as medical devices
– particularly those with long and small lumina,
joints, and/or crevices between components – are
difficult or impossible to clean once body fluids
or tissues with potential pyrogenic or microbial
contamination have had contact with the medical
device for an indeterminable period of time. The
residue of biological material can promote the
contamination of the device with pyrogens or
microorganisms which may lead to infectious
complications.
3. Do not resterilize. After resterilization, the sterility
of the product is not guaranteed because of an
indeterminable degree of potential pyrogenic
or microbial contamination which may lead to
infectious complications. Cleaning, reprocessing,
and/or resterilization of the present medical device
increases the probability that the device will
malfunction due to potential adverse effects on
components that are influenced by thermal and/or
mechanical changes.
4. To reduce the potential for vessel damage, the
inflated diameter and length of the balloon should
approximate the diameter and length of the vessel
just proximal and distal to the stenosis.
5. To reduce the potential for stent or stent graft
damage and/or vessel damage from the stent or
stent graft, the diameter of the balloon should
be no greater than the diameter of the stent or
stent graft. Refer to the stent or stent graft IFU
for safety information including the WARNINGS,
PRECAUTIONS, and potential ADVERSE EFFECTS
regarding the use of balloon post-dilatation.
6. When the catheter is exposed to the vascular
system, it should be manipulated while under
high-quality fluoroscopic observation. Do not
advance or retract the catheter unless the
balloon is fully deflated. If resistance is met
during manipulation, determine the cause of the
resistance before proceeding. Applying excessive
force to the catheter can result in tip breakage or
balloon separation.
7. Do not exceed the RBP recommended for this
device. Balloon rupture may occur if the RBP
rating is exceeded. To prevent over pressurization,
use of a pressure monitoring device is
recommended.
8. After use, this product may be a potential
biohazard. Handle and dispose of in accordance
with acceptable medical practices and applicable
local, state, and federal laws and regulations.
Precautions
1. Carefully inspect the catheter prior to use to verify
that catheter has not been damaged during shipment
and that its size, shape, and condition are suitable for
the procedure for which it is to be used. Do not use if
product damage is evident.
®
2. The Atlas gold Catheter shall only be used by
physicians trained in the performance of Percutaneous
Transluminal Angioplasty.
3. The minimal acceptable sheath French size is printed
on the package label. Do not attempt to pass the PTA
catheter through a smaller size sheath introducer than
indicated on the label.
4. Do not remove the guidewire in situ to shoot contrast
through the wire lumen or perform a wire exchange.
If the wire is removed while the balloon catheter is
situated in tortuous anatomy, the risk of kinking the
catheter is increased.
5. Use the recommended balloon inflation medium
(a range of 30-50% contrast medium / a range of
50-70% sterile saline solution). It has been shown
that a 30/70% contrast/saline ratio has yielded faster
balloon inflation / deflation times.
6. Never use air or other gaseous medium to inflate the
balloon.
7. If resistance is felt during post procedure withdrawal of
the catheter through the introducer sheath, determine
if contrast is trapped in the balloon with fluoroscopy. If
contrast is present, push the balloon out of the sheath
and then completely evacuate the contrast before
proceeding to withdraw the balloon.
8. If resistance is still felt during post procedure
withdrawal of the catheter, it is recommended to
remove the balloon catheter and guidewire/introducer
sheath as a single unit.
9. Do not continue to use the balloon catheter if the shaft
has been bent or kinked.
10. Prior to re-insertion through the introducer sheath,
the balloon should be wiped clean with gauze, rinsed
with sterile normal saline, and refolded with the
balloon re-wrap tool. Balloon re-wrapping should only
occur while the balloon catheter is supported with a
guidewire.
Potential Adverse Reactions
The complications which may result from a peripheral
balloon dilatation procedure include:
• Acute thrombotic occlusion
• Additional intervention
• Allergic reaction to drugs or contrast medium
• Aneurysm or pseudoaneurysm
• Arrhythmias
• Balloon rupture
• Balloon getting stuck on stent
• Distal embolization (PE)
• Hematoma
• Hemorrhage, including bleeding at the puncture site
• Hypotension/hypertension
• Inflammation
• Leg edema
• Occlusion
• Pain or tenderness
• Pneumothorax or hemothorax
• Sepsis/infection
• Shock
• Short term hemodynamic deterioration
• Stent disruption or dislodgement with balloon insertion
• Stroke
• Thrombosis
• Vessel dissection, perforation, rupture, or spasm
Directions for Use
Handling & Storage
Store in a cool, dry, dark place. Do not store near radiation
or ultra-violet light sources.
Rotate inventory so that the catheters and other dated
products are used prior to the "Use By" date.
Do not use if packaging is damaged or opened.
Equipment for Use
• Contrast medium
• Sterile saline solution
• Luer lock syringe/inflation device with manometer
(10 ml or larger)
• Appropriate introducer sheath and dilator set
• .035" guidewire
Dilatation Catheter Preparation
1. Remove Catheter from package.
1
2. Verify the balloon size is suitable for the procedure and
the selected accessories accommodate the catheter
as labeled.
3. Remove the balloon guard by grasping the balloon
catheter just proximal to the balloon and with the other
hand, gently grasp the balloon protector and slide
distally off of the balloon catheter.
4. Slide the re-wrap tool to the proximal end of the
catheter shaft.
5. Prior to use, the air in the balloon catheter should
be removed. To facilitate purging, select a syringe or
inflation device with a 10 ml or larger capacity and fill
approximately half of it with the appropriate balloon
inflation medium (30-50% contrast medium / 50-70%
sterile saline solution). Do not use air or any gaseous
medium to inflate the balloon.
6. Connect a stopcock to the balloon inflation female luer
hub on the dilatation catheter.
7. Connect the syringe to the stopcock.
8. Hold the syringe with the nozzle pointing downward,
open the stopcock, and aspirate for approximately
15 seconds. Release the plunger.
9. Repeat step #8 two more times or until bubbles no
longer appear during aspiration (negative pressure).
Once completed, evacuate all air from the barrel of the
syringe/inflation device.
10. Prepare the wire lumen of the catheter by attaching a
syringe to the wire lumen hub and flushing with sterile
saline solution.
®
Use of the Atlas gold PTA Dilatation Catheter
®
1. Backload the distal tip of the Atlas gold Catheter
over the pre-positioned guidewire and advance the tip
to the introduction site.
2. Advance the catheter through the introducer sheath
and over-the-wire to the site of inflation. If the stenosis
cannot be crossed with the desired dilatation catheter,
use a smaller diameter catheter to pre-dilate the lesion
to facilitate passage of a more appropriately sized
dilatation catheter.
3. Position the balloon relative to the lesion to be dilated,
ensure the guidewire is in place and inflate the balloon
to the appropriate pressure.
4. Apply negative pressure to fully evacuate fluid from the
balloon. Confirm that the balloon is fully deflated under
fluoroscopy.
5. While maintaining negative pressure and the position
of the guidewire, withdraw the deflated dilatation
catheter over-the-wire through the introducer sheath.
Use of a gentle clockwise motion may be used to
help facilitate catheter removal through the introducer
sheath.
Balloon Reinsertion
Precaution: Do not continue to use the balloon catheter if
the shaft has been bent or kinked.
Precaution: Prior to re-insertion through the introducer
sheath, the balloon should be wiped clean with gauze,
rinsed with sterile normal saline, and refolded with the
balloon re-wrap tool. Balloon re-wrapping should only
occur while the balloon catheter is supported with a
guidewire.
1. Load the balloon catheter onto a guidewire.
2. Advance the balloon re-wrap tool over the catheter to
the proximal end of the balloon.
3. Grasp the catheter shaft just proximal to the balloon
with one hand, and with the other hand gently slide
the rewrap tool over the balloon to the catheter tip and
then back over the balloon to the catheter.
4. Slide the re-wrap tool to the proximal end of the
catheter shaft.
5. Advance the balloon catheter over the pre-positioned
guidewire to the introduction site and through the
introducer sheath. If resistance is encountered, replace
the previously used balloon catheter with a new
balloon.
6. Continue the procedure according to the "Use of the
®
Atlas gold PTA Dilatation Catheter" section herein.
Warning: After use, this product may be a potential
biohazard. Handle and dispose of in accordance with
acceptable medical practices and applicable local,
state and federal laws and regulations.
Clinical Experience
Design
A physician sponsored, single center, retrospective study
was conducted to assess the safety and effectiveness
®
of the Atlas gold PTA Dilatation Catheter for balloon
dilatation in iliac and femoral deep venous procedures up
to one year post-procedure. Sixty-one patients treated with
®
the Atlas gold PTA Dilatation Catheter of the iliofemoral
veins were included.
The primary safety endpoint was defined as intra-
procedural freedom from major adverse events (MAE)
of ≥95%, defined as acute thrombosis, perforation, or
device-related complications. The secondary endpoints
were in-hospital and1 month freedom from MAE; minimal
luminal area (MLA) post-stent minus MLA pretreatment at
compression site using intravascular ultrasound (IVUS)