The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident 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, the diamondback peripheral orbital atherectomy device (oad) became stuck on the guide wire, and part of the spring tip of the guide wire broke.The highly calcified, 99% stenosed target lesion was located throughout the anterior tibial (at) artery and wired via a pedal access.The anterior tibial artery was 2-3mm in diameter and portions had moderate tortuosity.After two treatment passes, the tip of the guide wire was observed to be fractured.The fragment was approximately half of the guide wire spring tip and was located in a geniculate where it was not obstructing flow.It was determined there was no way to retrieve the fragment, and the fragment was left in vivo.The procedure was continued with a second oad and completed with balloon angioplasty.Following the procedure, the patient was fine, and the anterior tibial artery was open and flow had been restored.
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