The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.The diamondback peripheral orbital atherectomy system instructions for use warns that a vessel perforation is a potential adverse event that may occur, and/or require intervention.Csi id: (b)(4).
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During a procedure, the viperwire guide wire was inadvertently advanced into the collateral artery and the diamondback peripheral orbital atherectomy device (oad) shut down after becoming stuck in the vessel.After one hour of troubleshooting, a balloon was used to free the oad from the vessel and a small perforation was identified.A prolonged balloon inflation was used to resolve the perforation and the patient was stable following the procedure.Per the opinion of the physician, the cause of the perforation event was due to inadvertently operating in the collateral artery.
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