CONTRAINDICATIONS
The GORE® Molding and Occlusion Balloon Catheter is contraindicated in patients who: • are contraindicated to contrast media or anticoagulants • have an arterial entry site that cannot accommodate a 10 Fr introducer sheath • are minors • are pregnant
WARNINGS
• Excessive inflation volume may result in balloon rupture, embolization, vessel damage, vessel rupture, or patient death. • Do not continue if resistance is felt during advancement or retraction of the balloon catheter. Stop and assess the cause of the resistance. • Continued movement against resistance may result in prosthesis migration, vessel damage, and / or catheter damage. • Do not advance or retract the balloon catheter while the balloon is inflated. Ensure the balloon is deflated by locking the balloon inflation stop cock while maintaining a vacuum on the syringe and using fluoroscopy to confirm balloon complete deflation before moving the balloon catheter. • Do not inflate the balloon in areas of significant calcified plaque. Balloon rupture and / or vessel damage may occur. • If the deflated balloon catheter gets caught on the leading edge of the introducer sheath during retraction, carefully push the balloon catheter forward until it is outside the introducer sheath, slightly re-inflate then deflate the balloon until a vacuum is applied, while maintaining a vacuum on the balloon / syringe, re-lock the balloon inflation stopcock. While keeping the introducer sheath stationary, carefully try to retract the balloon catheter into the introducer sheath. Alternative methods are to pull the guidewire back until the leading guidewire tip is well inside the balloon catheter and / or to pull the introducer sheath back slightly until the leading tip of the sheath and balloon 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. • Incorrect usage of the balloon catheter may result in prosthesis movement and may require additional prosthesis placement or surgical intervention. • Observe inflation and deflation of the balloon under fluoroscopy to ensure proper functioning of the balloon catheter. Withdrawal of the balloon catheter prior to deflation may result in prosthesis migration, vessel damage, and / or catheter damage. • Do not use high pressure injector. • Do not use the GORE® Molding and Occlusion Balloon Catheter for more than 20 inflation / deflation cycles.
PRECAUTIONS
• Do not resterilize. The GORE® Molding and Occlusion Balloon Catheter is intended for single use only. • Do not use after the labeled "use by" (expiration) date. • Do not use device if damaged or if sterile barrier has been compromised.
