The reported oad was received for analysis.The nose cone of the device was damaged as a result of an apparent impact, which may have been due to the device being shipped without the protective tray.Adhered biological material was observed on the driveshaft, crown, and proximal spring tip coils.The oad was found to function as intended with no abnormalities observed.The damage to the driveshaft and nose cone prohibited complete functional testing of the device, therefore the reported crown jumping was unable to be replicated.The reported guide wire was not received for analysis.At the conclusion of the device analysis investigation, the cause of the reported event was unable to be confirmed.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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During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a device malfunction occurred leading to a procedural delay.The target lesions were located in the distal superficial femoral artery (sfa) and anterior tibial artery (at).When the oad was powered on to begin treatment, the crown was noted to move approximately 3 cm outside of operator control.The device was repositioned, however when it was powered on the crown jumped again.The lesion in the sfa was treated using one pass with the oad, however the uncontrolled movement occurred two more times.The oad was removed and the procedure was completed using balloon angioplasty.It was reported that the device issue led to a 30 minute procedural delay.No consequences to the patient were reported.
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