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Peripheral ROTAPRO™ Rotational Atherectomy System

Indications, Safety, and Warnings

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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The Peripheral ROTAPRO is intended for percutaneous use in the peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.

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 Peripheral ROTAPRO. Such patients may be treated with thrombolytics (e.g., Urokinase).
  5. Angiographic evidence of significant vessel trauma at the treatment site.
     

WARNINGS

  • If the Peripheral ROTAPRO shows evidence of mechanical failure at any time prior to or during the atherectomy procedure, immediately discontinue use of the device and return it to Boston Scientific Customer Service for evaluation. Do NOT attempt to use a damaged Peripheral ROTAPRO; use may result in device malfunction and/or patient injury.
  • The use of Peripheral ROTAPRO for in-stent restenosis might lead to damage of stent components and/or the Peripheral ROTAPRO, which may lead to patient injury.
  • Percutaneous rotational atherectomy with the Peripheral ROTAPRO 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.

PRECAUTIONS

  • Appropriate drug therapy including (but not limited to) anticoagulant/antiplatelet and vasodilator therapy must be provided to the patient during all phases of patient care.
  • When any component of the Peripheral ROTAPRO are in the body, they should only be manipulated under fluoroscopic guidance with radiographic equipment capable of high resolution images.
  • Use only normal saline or saline mixed with Rotaglide™ lubricant as the infusate. Never use contrast material, or any other substance that is not approved as part of the ROTAPRO System, in the infusion port or saline infusion bag as this may cause permanent damage to the Peripheral ROTAPRO.

ADVERSE EVENTS

Potential adverse reactions which may result from the use of this device include but are not limited to:

  • Allergic reaction (to drug, contrast, device or other)
  • Cerebrovascular accident (CVA)/Stroke/Transient ischemic attack (TIA)
  • Death
  • Electric shock
  • Embolism (e.g. air, plaque, thrombus, device, tissue, or other)
  • Hematoma
  • Hemorrhage
  • Hypotension/hypertension
  • Infection/Sepsis
  • Ischemia
  • Need for additional intervention or surgery, including amputation
  • Pain
  • Restenosis
  • Thrombus/thrombosis
  • Vasospasm
  • Vessel occlusion
  • Vessel trauma (e.g. dissection, AV fistula, perforation, pseudoaneurysm, rupture)

 

92934027 AB

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