AccuStick™ II Introducer System with RO Marker

Prescriptive Information

Refer to the Instructions for Use for complete instructions for use.

Cautions

Federal (USA) law restricts this device to sale, distribution and use by or on the order of a physician.

Indications

The AccuStick II Introducer System with Radiopaque Marker facilitates introduction and placement of a guidewire.

Contraindications

None known

Warnings

None known

Potential Adverse Effects

Potential risks exist for serious complications to include:

• Perforation of a vessel or viscus
• Laceration of a vessel or viscus
• Bleeding
• Wire or catheter embolism
• Extravasation
• Hematoma
• Hemothorax
• Hydrothorax
• Inflammation, necrosis or scarring
• Risks normally associated with percutaneous interventional procedures
• Pain in region
• Skin infection
• Edema

These and other complications are well documented in medical literature. Use of the AccuStick II Introducer System with Radiopaque Marker should be reserved by persons knowledgeable of the risks involved and qualified in the procedures.

Cautions

Sterile. For single use only. Do not reuse or resterilize.

These products are supplied sterile. If the catheter package is opened or damaged, do not use products.

Device should be used for non-vascular procedures only.

Advancement and/or withdrawal of 0.46/0.97mm (0.018"/0.038") wires should be smooth and without resistance. DO NOT USE EXCESSIVE FORCE. If resistance is felt, carefully remove wire(s) and system as a unit.