The oad and guide wire were returned to csi.Visual analysis found biological material on the distal driveshaft and crown.The returned guide wire successfully passed through the section with biological material.The morphology and exact root cause of the accumulated biological material could not be conclusively determined.The device history record for this device lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event and the device met material, assembly, and quality control requirements prior to distribution.Csi id: (b)(4).
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The stealth 360 peripheral orbital atherectomy device (oad) was used for treatment in the superficial femoral artery (sfa), which had soft calcium.The oad was spun on low speed for three treatments and then spun on medium speed.The patient expressed pain and the oad produced an unusual noise.At this time, the physician felt the oad "buckled" and therefore removed the oad.Intravascular ultrasound (ivus) was reviewed, and no dissection was observed.The oad was removed, and tissue was observed on the driveshaft.Based on this, the physician believed a dissection may have occurred at the ostium of the vessel.Angioplasty and stent placement were performed to complete the procedure.The patient was stable.
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