ZIPwire™ Hydrophilic Guide Wire

Indications, Safety, and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. 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.

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 Hydrophilic Guide Wire 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 dislodgment. The physician should be familiar with the literature concerning the complications of angiography.

ADVERSE EVENTS

Potential adverse events (in alphabetical order) that may be associated with the use of a guide wire include, 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

• Pseudoaneurysm

• Renal Failure

• Stroke

• Vascular thrombosis

• Vessel occlusion

• Vessel perforation, dissection, trauma, or damage

• Vessel spasm

Top