Journey™ Guidewire

Indications, Safety and Warnings

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.

INTENDED USE/INDICATIONS FOR USE

Journey™ Guidewires are intended to facilitate placement and exchange of balloon dilatation catheters or other therapeutic devices during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures. The Journey Guidewires are not intended for use in the cerebral vasculature. The devices are provided nonpyrogenic, sterile, and intended for one procedure only.

CONTRAINDICATIONS

The Journey Guidewire is not intended for use in the cerebral vasculature.

WARNINGS

The Journey Guidewires should be used only by physicians trained in angiography and PTA. Vessel trauma may result from the improper use of this device. Follow the enclosed directions carefully. When the guidewire is in the body, it should be manipulated only under fluoroscopy.

PRECAUTIONS

Carefully check and match therapeutic device compatibility to the wire prior to use.

ADVERSE EVENTS

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

• Allergic reaction

• Contrast induced renal insufficiency or renal failure

• Death

• Embolism

• Hematoma at the puncture site

• Hemorrhage

• Infection

• Pseudoaneurysm

• Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA)

• Vascular thrombus

• Vessel spasm

• Vessel trauma (dissection, perforation, rupture or injury)

Some of the above potential adverse events may require additional surgical intervention.

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