During a peripheral atherectomy procedure using a csi orbital atherectomy device, the device became stuck in the patient and surgical removal was required.The target lesion was 100% stenosed and located in the distal pedal arch.During treatment with the oad, the device became stuck.Multiple attempts were made to dislodge the device using additional guide wires and a balloon, however they were unsuccessful.Surgery was performed to remove the device and the patient was well following the procedure.
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The driveshaft of the reported oad was received for analysis.The body of the oad was not returned.The driveshaft and crown were observed to have been destructively cut and the presence of adhered biological material was noted.The saline sheath was found to be stretched and the driveshaft section was damaged, deformed and severely elongated.Based on the lesion and vessel details provided to csi, it is possible that the device was operated in a small vessel which may have contributed to the device becoming stuck.However, this could not be conclusively determined through device analysis.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.(b)(4).
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