Amplatz Super Stiff™ Guidewire

INTENDED USE/INDICATIONS FOR USE

The Amplatz Super Stiff guidewire facilitates catheter placement and exchange during diagnostic or interventional procedures. Not intended for use in coronary arteries. The tip of the guidewire is not designed to be reshaped. Reshaping of the tip could result in damage to the guidewire. Attention should be paid to guidewire movement in the vessel. Always advance or withdraw a wire slowly. Never push, auger, or withdraw a guidewire which meets resistance. Resistance may be felt tactilely or noted by tip buckling during fluoroscopy. When reintroducing a guidewire into a catheter within a vessel, confirm that the catheter tip is free within the lumen (i.e. not against the vessel wall). Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative.

CONTRAINDICATIONS

None known.

WARNINGS

This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated.

ADVERSE EVENTS

Potential adverse events which may result from the use of the device include but are not limited to:

Air Embolism/Thromboembolism, Allergic Reaction, Amputation, Arteriovenous (AV) Fistula, Death, Embolism, Hematoma, Hemorrhage, Hemoglobinuria, Infection or Sepsis/Infection, Myocardial Ischemia and/or Infarction, Pseudoaneurysm, Stroke (CVA)/Transient Ischemic Attacks (TIA), Thrombus, Vessel Occlusion, Vessel Perforation/ Dissection/Trauma, Vessel Spasm, Wire Entrapment/Entanglement, Foreign body/Wire Fracture. Some of the stated potential adverse events may require additional surgical intervention.