Hi-Torque Connect™ 250T

Important Safety Information

Indications

Hi-Torque Guide Wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.

Contraindications

Hi-Torque Wires are not intended for use in the coronary and cerebral vasculature or in patients judged not acceptable for percutaneous intervention.

Warnings

• A guide wire is a delicate instrument and must not be advanced, withdrawn, or torqued if resistance is met. Guide wire manipulations must always be observed under fluoroscopy. • The Hi-Torque™ family of guide wires has distal ends of varying stiffness. Operate these guide wires carefully so as to not injure the blood vessel, observing the information in these instructions. The higher torque performance, stiffer distal ends, and / or higher advancement force may present a higher risk of perforation or injury than a guide wire with a more pliable distal end. Therefore, use the guide wire with the least stiff distal end that will treat the lesion, and use extreme care to minimize the risk of perforation or other damage to blood vessels. • If the guide wire is removed and is to be re-inserted, it must be inspected for signs of damage (weakened or kinked segments) prior to re-introduction. Do not re-introduce if guide wire is weakened or kinked.

Do Not:
• Push, auger, withdraw, or torque a guide wire that meets excessive resistance. • Torque a guide wire if the tip becomes entrapped within the vasculature. • Allow the guide wire tip to remain in a prolapsed condition.

Do:
• Advance or withdraw the guide wire slowly. • Use the radiopaque marker of the interventional device to confirm position. • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire. • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance. • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma. • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall. • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.

Precautions

• Failure to follow the instructions may compromise guide wire performance and result in complications. • Prior to use, confirm compatibility of guide wire outer diameter with the balloon catheter. • Guide wire advancement, withdrawal, and torquing should be monitored by fluoroscopy.