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.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Csi id: (b)(4).
|
During treatment of the posterior tibial artery, the diamondback 360 peripheral orbital atherectomy device (oad) micro crown perforated the vessel.The oad was removed and a balloon was advanced across the perforation and inflated for two minutes to occlude flow.After the balloon was deflated, the perforation was no longer visible.The procedure was completed successfully.The patient was stable.
|