ZIPwire® Hydrophilic Guide Wire

Prescriptive Information

Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.

Intended Use: To facilitate the placement of devices during diagnostic and interventional procedures.

Contraindications: There are no known Contraindications.

Adverse Events: Potential adverse events (in alphabetical order) which maybe associated with the use of a guidewire, but are not limited to, the following: Allergic reaction, amputation, death, delayed immune response, embolism, febrile reaction, hematoma, hemorrhage, infection, myocardial ischemia and/or infarction, pseudo aneurysm, renal failure, stroke, vascular thrombosis, vessel occlusion, vessel perforation, dissection, trauma, or damage, vessel spasm.

Warnings: Failure to abide by the following warnings might result in damage to the vessel, shearing of the ZIPwire Hydrophilic Guide Wire and release of plastic fragments from the ZIPwire Hydrophilic Guide Wire. Such pieces or fragments from the ZIPwire may have to be removed from the vessel.

When using a guide wire, potential exists for thrombus formation or emboli, arterial or venous wall damage and/or plaque dislodgement. The physician should be familiar with the literature concerning the complications of angiography.

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