Adverse Events; How Supplied; Operational Instructions - Stryker Neurovascular TransForm Mode D'emploi

PrECaUTIOnS
• To facilitate balloon catheter handling, the proximal portion of the balloon catheter does
not have a hydrophilic surface. Greater resistance may be encountered when this section
of the balloon catheter is advanced into the Rotating Hemostatic Valve (RHV).
• Exercise care in handling the balloon catheter during a procedure to reduce the
possibility of accidental breakage, bending or kinking.
• To control introduction, movement, positioning and removal of the balloon catheter
within the vascular system, users should employ standard clinical angiographic and
fluoroscopic practices and techniques throughout the interventional procedure.
• The TransForm™ Occlusion Balloon Catheter has not been tested in coronary vessels.
• The TransForm Occlusion Balloon Catheter is not intended for angioplasty treatment of
intracranial atherosclerotic disease.
• Use prior to the "Use By" date shown on the package label. Aging beyond use by date
may result in material degradation resulting in adverse performance of the product.
• 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.
• Use caution while removing contents from packaging. Rapid removal or jerking from the
package may cause catheter damage.
• Do not reinsert the balloon catheter into the dispenser coil. Reinserting the balloon
catheter into the dispenser coil may cause kinking or damage to the balloon catheter.
Once the balloon catheter has been hydrated, do not allow to dry.

aDVErSE EVEnTS

Potential adverse events associated with the use of balloon catheters or with the endovascular
procedures include, but are not limited to:
• Access site complications
• Allergic reaction
• Aneurysm perforation
• Aneurysm rupture
• Death
• Embolism (air, foreign body, plaque, thrombus)
• Hematoma
• Hemorrhage
• Infection
• Ischemia
• Neurological deficits
• Pseudoaneurysm
• Stroke
• Transient Ischemic Attack
• Vasospasm
• Vessel dissection
• Vessel occlusion
• Vessel perforation
• Vessel rupture
• Vessel thrombosis

HOw SUPPLIED

Stryker Neurovascular products are sterile and non-pyrogenic in unopened packaging that is
designed to maintain sterility unless the primary product pouch has been opened or damaged.
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
Handling and Storage
Store in a cool, dry, dark place.
Do not expose the catheter to organic solvents or ionizing radiation.

OPEraTIOnaL InSTrUCTIOnS

Preparations for Use
warning: 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.
warning: Verify device size, configuration and patient conditions are suitable for the specific
procedure.
Precaution: Use caution while removing contents from packaging. Rapid removal or jerking
from the package may cause catheter damage.
Place Guide Catheter
Prepare an appropriate guide catheter using instructions provided with the device. Establish and
maintain continuous flush with appropriate flush solution through the guide catheter per standard
practice (see Figure 1).
Prepare Occlusion Balloon Catheter
1. Gently remove contents from pouch using standard sterile technique.
2. Flush the balloon catheter dispenser (packaging) coil with 10 cc saline prior to removal of
product to activate the hydrophilic coating of the catheter.
3. Gently remove the balloon catheter from the dispenser coil.
Precaution: Do not reinsert the balloon catheter into the dispenser coil. Reinserting the
balloon catheter into the dispenser coil may cause kinking or damage to the balloon
catheter. Once the balloon catheter has been hydrated, do not allow to dry.
4. Connect a RHV to the balloon catheter luer fitting. Connect a 2-way stopcock to the RHV
and securely tighten. Attach a 3 cc syringe filled with a mixture of saline and contrast
solution to the RHV port.
5. Using the 3 cc syringe, flush the system verifying saline-contrast mixture exits the RHV.
Carefully tighten RHV and continue flushing to ensure saline-contrast mixture exits the distal
tip to fully purge the system of air. Observe the balloon during flush to avoid over inflation.
note: Partial inflation of the balloon during flushing may occur.
Line to flush
solution
(300 mm Hg) Stopcock
Guide
Catheter Hub
RHV
Guide
Catheter
Balloon
Catheter
0.014 in (0.36 mm) Guidewire
Figure 1. Example of Continuous Flush Setup
6. Carefully remove a recommended guidewire from its packaging and prepare the
guidewire according to manufacturer's instructions.
3
Syringe
RHV
Torque Device
Balloon
Syringe
Catheter Hub
Stopcock
Stryker Neurovascular
Black (K) ∆E ≤5.0