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 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.(b)(4).
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During a procedure with a diamondback peripheral orbital atherectomy device (oad), a perforation of the left anterior tibial artery occurred.Lesions in the superficial femoral artery and popliteal artery were successfully treated with orbital atherectomy and balloon angioplasty.At the end of the procedure, a perforation was noted in the left anterior tibial artery, and a blood pressure cuff was applied to the area.The patient was doing well following the procedure.The physician attributed the perforation to user error when advancing the balloon over the guide wire resulting in the guide wire advancing into a small side branch and not a device malfunction.
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