Terumo Azur CX 35 Instructions For Use Manual

Peripheral coil system
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Azur
CX 35 Peripheral Coil System
(Detachable)
Instructions for Use

DEVICE DESCRIPTION

The Detachable Azur CX 35 Peripheral Coil System (Azur
system) consists of a coil implant attached to a delivery system.
The coils are platinum-based coils with an inner layer of
hydrophilic polymer. The delivery pusher is powered by an Azur
Detachment Controller to selectively detach the coils. The Azur
Detachment Controller is provided separately.
The Azur system is available in a broad range of coil diameters
and lengths. The AZUR Detachable 35 coil must be delivered
through a double-braid reinforced catheter with the inner diameter
specified.
Table 1
Catheter I.D.
Coil Type
inches
AZUR Detachable 35
0.041- 0.047

INDICATIONS FOR USE

The Azur system is intended to reduce or block the rate of blood
flow in vessels of the peripheral vasculature. It is intended for use
in the interventional radiologic management of arteriovenous
malformations, arteriovenous fistulae, aneurysms, and other
lesions of the peripheral vasculature.
This device should only be used by physicians who have
undergone training in the use of the Azur system for embolization
procedures as prescribed by a representative from Terumo or a
Terumo-authorized distributor.
CONTRAINDICATIONS
Use of the Azur system is contraindicated in any of the following
circumstances:
When superselective coil placement is not possible.
When end arteries lead directly to nerves.
When arteries supplying the lesion to be treated are not
large enough to accept emboli.
When the A-V shunt is larger than the coil.
In the presence of severe atheromatous disease.
In the presence of vasospasm (or likely onset of
vasospasm).
POTENTIAL COMPLICATIONS
Potential complications include, but are not limited to: hematoma
at the site of entry, vessel/aneurysm perforation, unintended
parent artery occlusion, incomplete filling, vascular thrombosis,
hemorrhage, ischemia, vasospasm, edema, coil migration or
misplacement, premature or difficult coil detachment, clot
formation, revascularization, post-embolization syndrome, and
neurological deficits including stroke and possibly death.
The physician should be aware of these complications and
instruct patients when indicated. Appropriate patient
management should be considered.
Reposition
Time
mm
1.04 – 1.19
20 minutes
- 1 -

REQUIRED ADDITIONAL ITEMS

Appropriately sized catheter with double-braid support for
delivery of the AZUR system
Guidewires compatible with catheter
Rotating hemostatic Y valves (RHV)
Three-way stopcocks
Pressurized sterile saline drip
One-way stopcock
Stopwatch or timer

WARNINGS AND PRECAUTIONS

Caution: Federal law (USA) restricts this device to sale by or
on the order of a physician.
The Azur system is supplied sterile and non-pyrogenic
unless package is opened or damaged.
This device is intended for single use only. Do not reuse,
reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the
device and/or lead to device failure which, in turn, may result
in patient injury, illness, or death. Reuse, reprocessing, or
resterilization may also create a risk of contamination of the
device and/or cause patient infection or cross-infection,
including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the
device may lead to injury, illness or death of the patient.
Angiography is required for pre-embolization evaluation,
operative control, and post-embolization follow up.
Do not advance the delivery pusher with excessive force.
Determine the cause of any unusual resistance, remove the
Azur system, and check for damage.
Advance and retract the Azur system slowly and smoothly.
Remove the entire Azur system if excessive friction is noted.
If excessive friction is noted with a second Azur system,
check the catheter for damage or kinking.
The coil must be properly positioned in the vessel or
aneurysm within the specified reposition time from the time
the device is first introduced into the catheter. If the coil
cannot be positioned and detached within this time,
simultaneously remove the device and the catheter.
Positioning the device in a low-flow environment may
increase the reposition time.
If repositioning is necessary, take special care to retract the
coil under fluoroscopy in a one-to-one motion with the
delivery pusher. If the coil does not move in a one-to-one
motion with the delivery pusher, or if repositioning is difficult,
the coil may have become stretched and could possibly
break. Gently remove and discard the entire device.
Due to the delicate nature of the coils, the tortuous vascular
pathways that lead to certain lesions, and the varying
morphologies of the vasculature, a coil may occasionally
stretch while being maneuvered. Stretching is a precursor to
potential coil breakage and migration.
If a coil must be retrieved from the vasculature after
detachment, do not attempt to withdraw the coil with a
retrieval device, such as a snare, into the delivery catheter.
This could damage the coil and result in device separation.
Remove the coil, catheter, and any retrieval device from the
vasculature simultaneously.
Delivery of multiple coils is usually required to achieve the
desired occlusion of some vasculatures or lesions. The
desired procedural endpoint is usually angiographic
occlusion. The filling properties of the coils facilitate
angiographic occlusion.
Tortuosity or complex vessel anatomy may affect accurate
placement of the coil.
The long-term effect of this product on extravascular tissues
has not been established so care should be taken to retain
this device in the intravascular space.
PM-00861

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Summary of Contents for Terumo Azur CX 35

  • Page 1 One-way stopcock  DEVICE DESCRIPTION Stopwatch or timer The Detachable Azur CX 35 Peripheral Coil System (Azur WARNINGS AND PRECAUTIONS system) consists of a coil implant attached to a delivery system. The coils are platinum-based coils with an inner layer of Caution: Federal law (USA) restricts this device to sale by or hydrophilic polymer.
  • Page 2   Always ensure that at least two Azur Detachment Controllers Always handle the delivery pusher with surgical gloves. are available before starting an Azur system procedure.  Do NOT use in conjunction with radio frequency (RF)  The coil cannot be detached with any power source other devices.
  • Page 3 Detachment Controller. See Figure 2. Do not push the the coil may indicate that the coil could migrate once it is detached. DO NOT rotate the delivery pusher during or after detachment button at this time. 14. Wait three seconds and observe the indicator light on the delivery of the coil into the vasculature.
  • Page 4 Azur Detachment Controller is a single use device, preloaded with battery power, and packaged sterile. No Terumo Corporation recommends that the patient register the MR cleaning, inspection, or maintenance is required. If the conditions disclosed in this IFU with the MedicAlert Foundation or device does not perform as described in the Detachment equivalent organization.
  • Page 5 Terumo’s obligation under this warranty is limited to the repair or replacement of this device through its expiration date. Terumo shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of this device.
  • Page 6 Azur system for embolization remove the device and the microcatheter. Positioning the procedures as prescribed by a representative from Terumo or a device in a low-flow environment may increase the reposition Terumo-authorized distributor.
  • Page 7   The coil cannot be detached with any power source other Always handle the delivery pusher with surgical gloves. than an Azur Detachment Controller.  Do NOT use in conjunction with radio frequency (RF)  Do NOT place the delivery pusher on a bare metallic devices.
  • Page 8 injection or flow of steam, gently retract the implant back completely into the introducer sheath about 1 to 2 cm. INTRODUCTION AND DEPLOYMENT OF THE AZUR SYSTEM 20. Open the RHV on the microcatheter just enough to accept the introducer sheath of the Azur system. 21.
  • Page 9 the microcatheter lumen to ensure that no part of the last coil remains within the microcatheter. The physician has the discretion to modify the coil deployment technique to accommodate the complexity and variation in embolization procedures. Any technique modifications must be consistent with the previously described procedures, warnings, precautions and patient safety information.
  • Page 10 Terumo’s obligation under this warranty is limited to the repair or replacement of this device through its expiration date. Terumo shall not be liable for Terumo Corporation recommends that the patient register the MR...
  • Page 11 Azur system for embolization procedures as both the device and delivery catheter from the patient. prescribed by a representative from Terumo or a Terumo-authorized  Do not use a syringe to deliver the coil. The coil is intended to be distributor.
  • Page 12   Tortuosity or complex vessel anatomy may affect accurate Always advance an appropriately-sized guidewire through the placement of the coil. delivery catheter after deployment to ensure that no part of the coil remains within the catheter prior to delivering the next coil or ...
  • Page 13 Complete the deployment within 3 minutes. After 3 minutes, swelling of the hydrophilic polymer may Terumo Corporation recommends that the patient register the MR prevent passage through the delivery catheter and result in conditions disclosed in this IFU with the MedicAlert Foundation or damage to the coil.
  • Page 14 Terumo’s obligation under this warranty is limited to the repair or replacement of this device through its expiration date. Terumo shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of this device.
  • Page 15 Azur system for embolization the coil may have become stretched and could possibly procedures as prescribed by a representative from Terumo or a break. Gently remove and discard the entire device. Terumo-authorized distributor.
  • Page 16 Figure 1 – Diagram of Azur System Setup 11. For vessel occlusion, select a coil size that is slightly larger than PREPARATION FOR USE the vessel diameter. 12. Correct coil selection increases effectiveness and patient safety. Refer to Figure 1 for the set-up diagram. Occlusive efficiency is, in part, a function of compaction and Attach a rotating hemostatic valve (RHV) to the hub of the guiding overall coil mass.
  • Page 17 controller in the sterile field. The Azur Detachment Controller is the coil size is not suitable, remove and replace with another packaged separately as a sterile device. Do not use any power device. If undesirable movement of the coil is observed under fluoroscopy following placement and prior to detachment, remove source other than the Azur Detachment Controller to detach the coil and replace with another more appropriately sized coil.
  • Page 18 Reuse, reprocessing, or resterilization may also create a risk of contamination of the Terumo Corporation recommends that the patient register the MR device and/or cause patient infection or cross-infection, conditions disclosed in this IFU with the MedicAlert Foundation or including, but not limited to, the transmission of infectious equivalent organization.
  • Page 19 Terumo’s obligation under this warranty is limited to the repair or replacement of this device through its expiration date. Terumo shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of this device.
  • Page 20 Detachable Instructions for Use ® PD110323 Rev. A MicroVention, Inc.
  • Page 21 This device should only be used by physicians who have undergone training in the use starting an Azur system procedure. of the Azur system for embolization procedures as prescribed by a representative from • The coil cannot be detached with any power source other than an Azur Terumo or a Terumo-authorized distributor. Detachment Controller. CONTRAINDICATIONS • Do NOT place the delivery pusher on a bare metallic surface.
  • Page 22 Line to flush solution 3-way stopcock Line to flush solution One-way stopcock 3-way stopcock Line to flush solution Azur delivery pusher proximal end connects to detachment controller Guide catheter Femoral sheath Coil Implant Microcatheter Microcatheter Distal Tip RO marker band Blood vessel Figure 1 –...
  • Page 23 Push the coil into the lumen of the microcatheter. Use caution to avoid catching 34. When the Azur Detachment Controller is properly connected to the delivery the coil on the junction between the introducer sheath and the hub of the pusher, a single audible tone will sound and the light will turn green to signal microcatheter.

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