Victory™ 14 & 18 Guidewire

Indications, Safety and Warnings

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Prescriptive Information

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

INDICATIONS FOR USE

The Victory guidewires are intended to facilitate the placement and exchange of balloon catheters or other interventional devices within the peripheral vasculature during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures.

CONTRAINDICATIONS

The Victory guidewires are not intended for use in the coronary or cerebral vasculatures or in patients judged not acceptable for percutaneous intervention.

WARNINGS/PRECAUTIONS

This device should be used only by physicians trained in percutaneous, intravascular techniques and/or procedures.

Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these instructions. Failure to do so may compromise guidewire performance and result in complications.

ADVERSE EVENTS

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

  • Hematoma and other access site complications
  • Death
  • Hemorrhage (bleeding)
  • Reaction to contrast media
  • Irritation to vessel causing vessel spasm
  • Vessel dissection or perforation
  • Thrombus formation
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