IMPORTANT SAFETY INFORMATION

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 ULTIMUM™/ ULTIMUM™ EV Hemostasis Introducer

APPLICATIONS

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

CAUTIONS

• 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• Damage to the valve assembly may occur if inner catheter is withdrawn rapidly.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.
• For Single Use Only! Single-use devices are designed and tested for only one patient application. These are disposable devices and are not designed for repro-cessing and reuse. Reuse of designated “single-use” devices creates a risk of patient or user infections due to prior patient use and the difficulty in cleaning the narrow structures at material interfaces following direct blood contact. Contami-nation or reprocessing cleaning agent residues may lead to adverse patient reactions and may damage the device. Use of non-St. Jude Medical packaging may compromise device functionality and sterility due to compromised protection from shipping and handling damage. The absence of labeling after reprocessing, may lead to misuse of the device and impaired traceability. Reprocessing and reuse may result in patient or user injury, permanent impairment or death.

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 perforation, cardiac arrhythmias, coronary artery spasm, embolism, thrombus formation, or death.