Indications and Safety Information

The AngioJet Series 3000 System with Power Pulse™ Delivery
Is intended for the control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system using the Xpeedior 120 Catheter and the AngioJet System.

The AngioJet Ultra Thrombectomy System with Power Pulse™ Delivery
Is intended for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

 CAUTION

• See product labeling for the AngioJet Drive Unit, Pump Set, and Catheter before using the Power Pulse Kit.
• The Power Pulse Kit assembly should only be used with the AngioJet Xpeedior 120 Catheter. DO NOT USE THE POWER PULSE KIT WITH OTHER ANGIOJET CATHETER MODELS.
• This system has NOT been tested for use in administering contrast medium. DO NOT ADMINISTER CONTRAST MEDIUM USING THIS SYSTEM.
• The AngioJet Power Pulse Technique should only be used by physicians whohave a thorough understanding of thrombectomy treatments and percutaneous interventional procedures.
• The guide wire/catheter must traverse beyond the targeted treatment zone prior to infusion of physician-specified fluid.
• Never leave the device unattended while running. Patient injury may occur.
• Refer to the product insert supplied with the physician-specified solutions used during Power Pulse Technique for contraindications, side effects,warnings and precautions.

CONTRAINDICATIONS
Do not use the Catheter in patients:

• Who are contraindicated for endovascular procedures;
• Who cannot tolerate contrast media;
• In whom the lesion cannot be accessed with the guide wire.

The Power Pulse Kit is not intended for use in the pulmonary, carotid, cerebral or coronary vasculature.

WARNINGS AND PRECAUTIONS

1. The AngioJet System, including the Power Pulse Kit, should be used only by operators who have received appropriate training in its installation and use.
2. Ensure the catheter tip is submerged in heparinized saline during operation outside the body to avoid undesired wetting of the sterile field or operator contamination.
3. Do not use in vessels smaller than 3.0 mm in diameter which may increase risk of vessel injury.
4. Do not use if sterile package is opened or damaged.The Kit is intended for single use only. Do not resterilize, reprocess, or reuse.
5. Visually inspect the Power Pulse Kit, and other AngioJet components, prior to use to ensure that no damage has occurred during shipment. Do not attempt use if any damage is noted.

ADVERSE EVENTS
Potential adverse events (in alphabetical order) which may be associated with use of the AngioJet Power Pulse Technique in peripheral vessels are similar to those associated with other interventional procedures and include but are not limited to:

• death
• dissection
• embolization
• hemolysis
• hemorrhage
• hypotension/hypertension
• pain
• perforation
• pseudoaneurysm
• thrombosis/occlusion
• total occlusion of treated vessel
• vascular aneurysm
• vascular spasm