Atherectomy was performed in the popliteal artery using a diamondback 360 orbital atherectomy device (oad).At least five treatments were performed proximal to distal.The guide wire was continually being pulled proximally by the scrub technician.When removing the oad, the tip of the viperwire advance guide wire fractured in a collateral vessel.Another guide wire was advanced as an attempt to remove the fractured fragment, however, due to the size of the vessel, the attempt was unsuccessful.The guide wire was removed.The physician decided to leave the radio opaque tip fragment in vivo.Following the procedure, the patient's condition was good and, was discharged home.
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The material inspection report for this guide wire 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 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.Csi id: (bb)(4).
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