Stryker Neurovascular TransForm Mode D'emploi page 2

TransForm
Occlusion Balloon Catheter
(Compliant and Super Compliant)
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
warnInG
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier
is damaged. If damage is found, call your Stryker Neurovascular representative.
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.
After use, dispose of product and packaging in accordance with hospital, administrative and/
or local government policy.
DEVICE DESCrIPTIOn
The TransForm Occlusion Balloon Catheter consists of a single lumen catheter shaft with a
balloon attached at the distal end. The balloon is available in a compliant version and a super
compliant version. Radiopaque markers are located at the proximal and distal ends of the balloon
to facilitate fluoroscopic visualization. The balloon catheter is recommended for use with a
Stryker Neurovascular 0.014 in (0.36 mm) guidewire to seal the distal segment of the catheter
lumen allowing inflation of the balloon. The guidewire can be moved distally or proximally once
beyond the distal tip (seal portion) of the catheter and still maintain a positive seal for inflating
the balloon. The distal outer segment of the catheter shaft is coated with a hydrophilic material
that reduces friction during manipulation in the vessel. A luer fitting hub at the proximal end of
the catheter is used for the attachment of accessories.
Contents
One (1) Occlusion Balloon Catheter
One (1) Compliance Chart
Table 1. Compatibility Information
Balloon Balloon Effective Max Catheter
Catheter OD Length Shaft OD
Type mm cm F (mm)
Compliant 3 150 2.8 (0.95)
Compliant 4 150 2.8 (0.95)
Compliant 5 150 2.8 (0.95)
Super
3 150 2.8 (0.95)
Compliant
Super
4 150 2.8 (0.95)
Compliant
Super
7 150 2.8 (0.95)
Compliant
Black (K) ∆E ≤5.0
™
Max Catheter
Min Guide recommended
Proximal
Catheter ID Guidewire OD
Balloon Bond
in (mm) in (mm)
OD F (mm)
Stryker Neurovascular
3.8 (1.30) 0.053 (1.35)
0.014 (0.36)
Stryker Neurovascular
3.8 (1.30) 0.053 (1.35)
0.014 (0.36)
Stryker Neurovascular
3.8 (1.30) 0.053 (1.35)
0.014 (0.36)
Stryker Neurovascular
3.8 (1.30) 0.053 (1.35)
0.014 (0.36)
Stryker Neurovascular
3.8 (1.30) 0.053 (1.35)
0.014 (0.36)
Stryker Neurovascular
3.8 (1.30) 0.053 (1.35)
0.014 (0.36)
Precaution: The TransForm Occlusion Balloon Catheter is designed specifically for use with
a Stryker Neurovascular 0.014 in (0.36 mm) guidewire. Compatibility with other guidewires
has not been established.
InTEnDED USE/InDICaTIOnS FOr USE
The Stryker Neurovascular TransForm Occlusion Balloon Catheter is indicated for use in
the neurovasculature to temporarily stop or control blood flow, for balloon-assisted coil
embolization of intracranial aneurysms, and as an adjunct to the medical management of
vasospasms or the treatment of refractory symptomatic cerebral vasospasms.
The Stryker Neurovascular TransForm Occlusion Balloon Catheter is indicated for use in the
peripheral vasculature to temporarily stop or control blood flow, and for balloon-assisted coil
embolization of aneurysms.
COnTraInDICaTIOnS
None known.
warnInGS
These devices should only be used by physicians who have received appropriate training in
neurointerventional surgery, interventional neuroradiology or interventional radiology.
• Use only with appropriate inflation media (of saline and contrast solution mixture). Do
not use oil-based contrast agents such as Lipiodol
agents can damage the balloon.
• The compatibility of the TransForm Occlusion Balloon Catheter has not been evaluated
with polyvinyl alcohol (PVA) particles or n-butyl cyanoacrylate (n-BCA).
• The balloon catheter is not intended to be used as an infusion catheter, for embolectomy
or subselective angiography. The balloon may inadvertently inflate if used for these types
of procedures.
• Presence of implanted devices such as clips and stents, and anatomical structures
or irregularities such as bone fragments or calcifications, may damage the balloon or
prevent entry/removal.
• Do not steam shape the catheter tip, as heat may damage the balloon material.
• The balloon should never be inflated or deflated with a pressure-based inflation device.
• Carefully inspect the balloon catheter prior to use. If product is damaged do not use and
contact your Stryker Neurovascular representative. Use of a damaged catheter may
cause serious injury.
• Verify device size, configuration and patient conditions are suitable for the specific procedure.
• Prior to introducing the balloon catheter system into the vasculature purge the system
carefully to avoid accidental introduction of air into the balloon catheter system. Failure
to do so may release trapped air during device use and cause neurological deficits. Do
not perform initial balloon flush while in the vasculature.
• Never advance or withdraw the balloon catheter system against resistance. Movement
of device against resistance could dislodge a clot, perforate a vessel wall, or damage the
device. If resistance is felt when advancing or removing the balloon catheter from the
guide catheter, carefully remove them as a unit to prevent damage to the blood vessel,
guide catheter or the device.
• Do not inflate the balloon beyond the diameter of the vessel being treated or beyond the
maximum allowed inflation volume (see tables 2-4). Excessive inflation volume may result
in a ruptured balloon or damage to the vessel. Do not move the balloon catheter while the
balloon is inflated.
• Withdrawing the guidewire into the balloon catheter past the distal tip (e.g., in-vivo
guidewire exchange, flushing the balloon, etc.) is not recommended due to the risk of
blood entry into the balloon. Blood in the balloon may result in risk of serious injury due
to poor balloon visualization and the potential of flushing embolic clots. If the guidewire
is withdrawn into the balloon catheter past the distal tip, withdraw the entire balloon
catheter system. Prior to reintroduction, prepare the balloon catheter system per the
directions in the Prepare Occlusion Balloon Catheter steps.
2
® or Ethiodol ® . Use of these contrast