RUNWAY™

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

Boston Scientific Guide Catheters are intended for use in general intravascular, coronary and peripheral applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

CONTRAINDICATIONS

None Known.

PRECAUTIONS

Check the labeled diameter of both the therapeutic device and guide catheter prior to use to ensure compatibility. Use of a power injector is not recommended. The large internal diameter of the catheter permits injection with little force being required on the syringe. Hand inject slowly whenever attempting to opacify the vessels via this catheter. The maximum recommended injection pressure is 500 psi /3447 kPa.

WARNINGS

Guide catheters are designed for use by physicians engaged in the practice of a specialized branch of medicine. Use of these devices should be restricted to those specialists trained to perform the procedure. A thorough understanding of the technical principles, clinical applications and risks associated with angioplasty is necessary before performing this procedure. Due to the size and relative stiffness of guide catheters, extreme care must be taken to avoid damage to the vessel walls through which this catheter passes. This catheter may occlude smaller vessels. Care must be taken not to completely block blood flow.

ADVERSE EVENTS

Potential adverse reactions which may result from the improper use of this device include:

• Arrhythmia

• Arteriovenus fistula

• Bleeding complications

• Cardiogenic shock/pulmonary edema

• Death

• Embolism

• Hematoma at the puncture site

• Hemorrhage

• Hypo/hypertension

• Infection

• Myocardial ischemia and/or infarction

• Neurological deficit including stroke

• Pseudoaneurysm

• Vascular thrombosis

• Vessel occlusion

• Vessel spasm

• Vessel trauma, including dissection, perforation and/or Rupture