GORE Tri-Lobe Mode D'emploi page 5

Balloon Catheter Withdrawal
1. When the procedure has been completed, deflate the balloons by drawing a vacuum on the balloon catheter and remove
from vasculature.
2. Observe deflation and withdrawal of the balloon catheter under fluoroscopy.
3. If the deflated balloon catheter gets caught on the leading edge of the introducer sheath during retraction, carefully push
the balloon catheter slightly forward, while keeping the introducer sheath stationary, and rotate the balloon catheter.
Carefully try to retract the balloon catheter into the introducer sheath. Alternative methods are to pull the guidewire back
until the guidewire tip is well inside the balloon catheter and / or to pull the introducer sheath back slightly until the tip
of the the sheath is in a straighter section of the vessel. At this point try retracting the balloon catheter from the sheath. If
resistance is still felt, remove the balloon catheter and the introducer sheath together.
BALLOON CATHETER RELATED ADVERSE EVENT REPORTING
Any adverse event involving the GORE® Tri-Lobe Balloon Catheter should be reported to W. L. Gore & Associates immediately. To
report an event in the US, call 800.437.8181. Outside the US, contact your local technical representative.
DEFINITIONS
Use By
Caution
Consult Instructions for Use
2
Do Not Resterilize
STERILIZE
Do Not Reuse
Catalogue Number
Batch Code
Serial Number
Authorised Representative in the European Community
CAUTION: USA Federal Law restricts the sale, distribution, or use of this device to, by, or on the order of a physician.
Sterile
Sterilized using Ethylene Oxide
Do Not Use if Package is Damaged
Keep Dry
Store in a Cool Place
Device Diameter (mm)
Guidewire Compatibility
Manufacturer
Date of Manufacture
Recommended Inflation Volume (ml)
3