Directions For Use - Stryker Neurovascular TransForm Mode D'emploi

7. Loosen the RHV and advance the guidewire through the RHV and into the balloon
catheter lumen so that the distal end of the guidewire is located proximal to the distal
seal of the TransForm™ Occlusion Balloon Catheter.
note: Make sure the guidewire tip is within the balloon section and not through the distal
end of the balloon catheter.
8. Flush the system again, verifying saline-contrast mixture exits the RHV. Carefully tighten
the RHV and continue flushing to ensure saline-contrast mixture exits the distal tip of
balloon catheter.
warning: 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.
9. Slightly loosen the RHV and advance the guidewire until aligned with the distal tip of the
balloon catheter to form a seal at the distal tip.
note: When Transend™ EX Platinum, Transend 300 ES or Transend 300 Floppy guidewires
are used as access guidewires, advance the guidewire at least 3 cm beyond the balloon
catheter tip to ensure seal integrity.
10. Using the 3 cc syringe, inflate the balloon with the saline-contrast mixture to the nominal
recommended inflation volume (refer to the compliance chart) and inspect the balloon
surface for any abnormalities (non-concentric shape, pin holes, etc.). While the balloon is
inflated, inspect for the presence of air bubbles.
11. If air is observed in the balloon catheter system, submerge the balloon catheter tip into
saline or contrast, loosen RHV slightly, pull the guidewire back from the distal tip of the
balloon catheter, and with the 3 cc syringe flush to purge air bubbles. Repeat steps 9 and
10 to ensure all air is purged from the balloon catheter.
12. With the tip of the balloon catheter system submerged in saline or contrast, slightly
loosen the RHV and withdraw the guidewire into the balloon to fully deflate the balloon.
13. Advance the guidewire tip to align with the balloon catheter tip. Tighten the RHV to hold
the guidewire in place.
14. Replace the 3 cc syringe with a 1 cc syringe filled with saline-contrast mixture.
note: To eliminate air bubble introduction into the RHV, fill the RHV port with saline-
contrast mixture prior to connecting the 1 cc syringe.

DIrECTIOnS FOr USE

1. Open the RHV on the guide catheter and introduce the balloon catheter system into the
guide catheter.
note: If Transend EX Platinum, Transend 300 ES or Transend 300 Floppy guidewires are
used as access guidewires, advance the guidewire by 3 cm as soon as the balloon
catheter system tip is through the RHV and inside the guide catheter. Maintain at least
3 cm wire advancement beyond the balloon catheter tip at all times.
2. Tighten the guide catheter RHV carefully around the balloon catheter system to prevent
back flow, but not so tightly as to inhibit catheter movement.
3. Advance the balloon catheter system until the fluoro saver marker reaches the guide
catheter RHV.
4. Under fluoroscopic guidance track the system distal to the desired treatment site.
Black (K) ∆E ≤5.0
warning: 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.
5. Position the balloon by pulling back the balloon catheter system to remove potential slack.
6. Confirm the balloon marker bands are positioned correctly relative to desired location.
7. Confirm that the guidewire is properly positioned at the distal seal to ensure balloon
inflation. To inflate the balloon, use the 1 cc syringe and slowly infuse the desired volume
of saline-contrast mixture (see Table 1 for nominal dimensions, and Tables 2-4 for volume/
diameter information).
warning: 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.
note: If the balloon is being used for an extended time such as for test occlusion,
additional infusion of saline-contrast mixture into the balloon may be required to maintain
intended balloon diameter.
8. Deflate the balloon by retracting the 1 cc syringe plunger. See tables 5-7 for deflation
time information.
note: It is not recommended to deflate the balloon by withdrawing the guidewire from the
distal seal, as this can result in blood being pulled into the catheter lumen.
warning: 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.
9. Fluoroscopically confirm the balloon has been deflated prior to withdrawal of the balloon
catheter system.
10. If re-insertion is desired, wipe clean with sterile saline and place in a basin of the
same solution.
Repeat steps from "Prepare Occlusion Balloon Catheter" section.
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