FAST-CATH™ INTRODUCER

IMPORTANT SAFETY INFORMATION

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 FAST-CATH™ Hemostasis Introducer

APPLICATIONS

The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential

CAUTION

• DO NOT alter this device.
• Federal law (U.S.) restricts this device to sale by or on the order of a physician.
• Do not attempt to use a guidewire over maximum diameter specified on package label.
• This device should only be used by physicians thoroughly trained in the technique of angiography and/or the use of St. Jude Medical catheter delivery systems.
• Individual patient anatomy and physician technique may require procedural variations.
• The closing force of the hemostasis valve may alter or impair the function of some catheters.
• Damage to guidewire may result if with-drawn through a metal needle cannula. Cannula must be removed first.
• Do not attempt to advance or withdraw guidewire if resistance is felt. Use fluo-roscopy to determine cause.
• Damage to the valve assembly may occur if inner catheter is withdrawn rapidly.
• Advance dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel
• STORE IN A COOL, DARK, DRY PLACE.

PRECAUTIONS

This device is intended for one time use only. Do not reprocess or reuse. Reuse can cause patient injury and/or the com-munication of infectious disease(s) from one patient to another

POTENTIAL ADVERSE EVENTS

Potential complications which may be encountered during all catheterization procedures include, but are not limited to: acute myocardial infarction or unstable angina, allergic reaction to the contrast media, arterial dissection, injury, or perfora-tion, cardiac arrhythmias, coronary artery spasm, embolism, thrombus formation, or death.