The reported oad was received for analysis.The driveshaft and saline sheath were noted to be kinked and deformed in multiple locations.This is consistent with attempting to pass the device through a guide sheath without success, however the root cause of the damage was unable to be conclusively determined.When tested, the oad functioned as intended with no anomalies noted.As the sheath and guide wire utilized during the procedure were not received for analysis, it was unable to be determined if they contributed to the reported event.At the conclusion of the device analysis investigation, the reported inability to pass the device through the guide sheath 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), the device was unable to pass through the sheath, resulting in a procedural delay.The oad was unable to pass through the 6f sheath in the distal superficial femoral artery.The sheath was replaced to a 7f sheath, however when loading the oad onto the guide wire it would not advance and the nose cone was noted to be damaged.Following a thirty minute delay, the device was replaced to complete the procedure and the patient remained in stable condition.
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