Boston Scientific

ROTAPRO Peripheral RotaLink Plus Instructions for Use Feb 2016

Instructions for Use

5 Pages

Rotablator™  RESTRICTIONS  Rotational Atherectomy System  • Federal (USA) law restricts the use of this system to physicians who are credentialed in peripheral angioplasty and who have attended the Rotablator System Physician Training Program.  Peripheral RotaLink Plus WARNINGS ™  Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device  ONLY Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. WARNING Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative. For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.  • The risks of Rotational Atherectomy can be reduced if the device and associated accessories are used in the appropriate patient population by a physician who has had adequate training. • If the Peripheral RotaLink Plus shows evidence of mechanical failure at any time prior to or during the angioplasty procedure, immediately discontinue use of the device and return it to Customer Service for evaluation. Do NOT attempt to use a damaged Peripheral RotaLink Plus; use may result in device malfunction and/or patient injury. • Never operate the Peripheral RotaLink Plus without saline infusion. Flowing saline is essential for cooling and lubricating the working parts of the advancer. Operation of the advancer without proper saline infusion may result in permanent damage to the advancer.  After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.  • Never operate the Peripheral RotaLink Plus with the Rotablator Rotational Atherectomy System in Dynaglide™ mode or operate the guidewire brake defeat button unless you have a firm grip on the guidewire using the wireClip™ Torquer. The wireClip Torquer may be held with the fingers or inserted completely into the docking port after the brake button is depressed. Defeating the brake, or operating the Peripheral RotaLink Plus with the Rotablator Rotational Atherectomy System in Dynaglide mode, without securing the guidewire may result in rotation and entanglement of the guidewire.  DEVICE DESCRIPTION  • During setup of the Peripheral RotaLink Plus never grip or pull on the flexible shaft.  The Rotablator Rotational Atherectomy System is a catheter-based angioplasty device utilizing a diamond-coated elliptical burr at the tip of a flexible drive shaft. Tracking coaxially over a guidewire and rotating at up to 190,000 RPM, the burr ablates plaque into fine particles that are disposed of by the body’s reticuloendothelial system. The Peripheral RotaLink Plus is provided STERILE and non-pyrogenic unless the package has been opened or damaged. It is intended for one procedure use only. Do NOT attempt to reuse or resterilize it. Contents Peripheral RotaLink Plus (1) Peripheral RotaLink Plus Assembly INTENDED USE/INDICATIONS FOR USE The Rotablator Rotational Atherectomy System is intended for percutaneous use in the peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures. CONTRAINDICATIONS AND RESTRICTIONS Contraindications 1. Occlusions through which a guidewire will not pass. 2. Use in coronary arteries. 3. Long (≥ 20 cm) total occlusions. 4. Angiographic evidence of thrombus prior to treatment with the Rotablator Rotational Atherectomy System. Such patients may be treated with thrombolytics (e.g., Urokinase). When the thrombus has been resolved for two to four weeks, the lesion may be treated with the Rotablator Rotational Atherectomy System.  CV 01  • The burr at the distal tip of the Peripheral RotaLink Plus is capable of rotating at very high speeds. Do NOT allow parts of the body or clothing to come in contact with the burr. Contact may result in physical injury or entanglement. • Never advance the rotating burr to the point of contact with the guidewire spring tip. Such contact could result in distal detachment and embolization of the tip. • If the Peripheral RotaLink Plus stops and the red STALL light on the console illuminates, retract the burr and immediately discontinue treatment. Check the advancer for proper connection to the console. If the connections are correct, use fluoroscopy to analyze the situation. Never force the system when rotational or translational resistance occurs, as vessel perforation may occur. • Never advance the rotating burr by advancing the sheath. Guidewire buckling may occur and perforation or vascular trauma may result. Always advance the rotating burr by using the advancer knob. • If resistance is encountered, retract the burr and stop treatment immediately. Use fluoroscopy to analyze the situation. Never force the Peripheral RotaLink Plus when rotational or translational resistance occurs, as vessel perforation, vessel trauma or embolism due to burr detachment or fractured wire may occur and in rare instances may result in surgical intervention and death. • The use of Rotablator Rotational Atherectomy System for in-stent restenosis might lead to damage of stent components and/or Peripheral RotaLink Plus, which may lead to patient injury. • A  lways keep the burr advancing or retracting while it is rotating. Maintaining the burr in one location while it is rotating may lead to excessive tissue removal or damage to the Peripheral  RotaLink Plus or entrapment of the Peripheral RotaLink Plus. It is best to advance and retreat the burr no more than 3 cm at a time in a smooth pecking motion, being careful to engage the lesion only minimally when resistance is met. Do not allow the individual burr run time to exceed 30 seconds with total rotational procedure time not to exceed five minutes. PRECAUTIONS • Percutaneous rotational angioplasty with the Rotablator Rotational Atherectomy System should only be carried out at medical facilities where prompt treatment can be immediately performed in the event of a potentially injurious or serious complication. • Appropriate drug therapy including (but not limited to) anticoagulant and vasodilator therapy must be provided to the patient during all phases of patient care. • When the Peripheral RotaWire™ Guidewires and/or Peripheral RotaLink Plus are in the body, they should only be manipulated while they are under fluoroscopic observation with radiographic equipment that provides high resolution images. • Use only normal saline as the infusate. Never inject contrast agent, or any other substance that is not approved as part of the Rotablator Rotational Atherectomy System, into the infusion port or saline infusion bag as this may cause permanent damage to the Peripheral RotaLink Plus. ADVERSE EVENTS Potential adverse reactions which may result from the use of this device include but are not limited to: • Additional intervention • Allergic reaction • Amputation • Death • Embolism • Hematoma/Hemorrhage • Hemodynamic changes • Hemoglobinuria • Infection • Restenosis • Stroke • Slow, no flow, abrupt vessel closure • Surgery including arterial bypass • Thrombosis and vessel occlusion • Vessel trauma (dissection, perforation, psudoaneurysm, arteriovenous fistula) There may also be complications associated with distortion, kinks, and fracture of the guidewire and physical deterioration or malfunction of the device, which can lead to patient injury or death. CLINICAL BACKGROUND Complications As with all interventional devices, serious complications, sometimes leading to death, may be associated with the use of the Rotablator Rotational Atherectomy System. Complications associated with the use of the Rotablator Rotational Atherectomy System have been compiled from literature, clinical trials, and reports received through the complaint handling system. Slow flow represents a reduction of flow, post Rotablator Rotational Atherectomy System treatment, by one to two TIMI grades from the baseline antegrade egress of dye. No flow represents the complete cessation of flow into the distal circulation of the treated vessel not associated with  Black (K) ∆E ≤5.0  Boston Scientific (Master Brand DFU Template 8.2677in x 11.6929in A4, 90105918AR), eDFU, MB, PI RotaLink Plus, en, 91119961-01A  2016-02 < en >  91119961-01  5. Angiographic evidence of significant dissection at the treatment site. The patient may be treated conservatively for approximately four weeks to permit the dissection to heal before treating the lesion with the Rotablator Rotational Atherectomy System.
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