Contraindications: In the US, the 0.9mm and 1.5mm catheters are not indicated for use in ISR lesions.

Warnings:

• The AURYON Atherectomy System is a Class IIb medical device which contains a Class IV laser that produces an invisible beam of high-energy ultraviolet radiation. Improper use of the AURYON Atherectomy System could result in serious personal injury. Observe all safety precautions for use of Class IV laser equipment.
• The AURYON Atherectomy System contains high voltages which are potentially lethal. To avoid electrical shock, do not open the AURYON Atherectomy System cover. Internal maintenance of the system must be performed only by personnel from AngioDynamics.
• Ensure the system is connected to the proper voltage. The voltage rating is marked on the back panel of the laser controller. Operating the system at the incorrect voltage may result in damage to the system units.
• The system is not intended to be used during a defibrillation event.
• Skin exposure to laser radiation should be avoided.
• Possible explosion hazard if the laser is used in the presence of flammable anesthetics or other solutions and gases. The laser beam may ignite solvents of adhesives and flammable solutions. Allow flammable materials to evaporate before the laser is used.
• Only catheters approved by AngioDynamics are allowed to be used in the AURYON Atherectomy System. AngioDynamics supplies sterile fiber optic catheters. Sterility is guaranteed only if the package is unopened, undamaged and before the expiry date.
• Pay attention when handling the AURYON OTW catheter to ensure that the fibers at the distal and proximal ends are not damaged.
• When moving the AURYON Atherectomy System be careful to avoid crashing or sudden impacts. Before moving the system, release the wheels from locking, disconnect the footswitch pedal cable from its connector in the laser system and place the footswitch pedal in the rear storage compartment. After the system is positioned for use, lock the wheels, take out the footswitch pedal from the rear storage compartment, connect the footswitch pedal cable to the laser system and place the footswitch pedal on the floor.

Adverse Events:

As with the use of similar therapies, the following potential complications may occur with the use of this catheter, accessories and adjunctive therapies (Balloon/stent). These complications may include but are not limited to:

• SeriousAdverse Events:
• Death
• Re-intervention
• ALI
• Major amputation
• Bypass surgery
• Hematoma with surgery
• Stroke
• Procedural Complications:
• Spasm
• Major dissection
• Thrombus
• Distal embolization
• Perforation
• In hospital complications:
• Re-occlusion
• Pseudoaneurysm
• Renal failure
• Bleeding
• Other AEs
• Nerve injury
• AV fistula formation
• Infection
• MI
• Arrhythmia

Warnings:

• Single patient use. Do not re-use or resterilize.
• Do not use if package is damaged.
• This product should be used only by physicians who have a thorough understanding of angiography and percutaneous interventional procedures.
• Do not inject contrast medium with a pressure injector if the occluding ball wire is in place.
• Use an introducer sheath if the puncture is through a synthetic graft.
• Failure to use an introducer sheath may result in damage to the catheter or occluding ball wire.
• Reprocessing may compromise the integrity of the device and/or lead to device failures.
• Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.
• Complications may occur, if all the air has not been removed from the infusion catheter and displaced with saline prior to insertion into the body.
• Never advance the guidewire against resistance; this could cause vessel trauma and/or wire damage. Determine the cause of resistance under fluoroscopy and take any necessary remedial action.

Potential Complications:

Potential Complications include, but are not limited to Hematoma at the entry site, Vessel perforation, Vasospasm, Hemorrhage, Contrast extravasation, Embolism, Drug reaction, Allergic reaction to contrast media, Neurological deficits including stroke and death, Pain and tenderness, Vessel dissection, Vascular thrombosis, Other – case (or patient) to which the therapeutic solution is inadequate.