CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE; PERIPHERAL ATHERECTOMY DEVICE
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Model Number DBP-150SOLID145 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/04/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.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.Csi id: (b)(4).
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Event Description
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A diamondback 360 peripheral orbital atherectomy device (oad) was used for treatment of three focal chronic total occlusions in the femoral and popiteal arteries.Each lesion was about 1cm in length.The oad was used on low, medium, and high speed one lesion at a time from proximal to distal.Imaging thereafter showed no flow at all below the knee, whereas flow had been present prior.The patient was sent to surgery for a thrombectomy and bypass.The patient was well following the procedure.In the opinion of the physician, no flow was caused by distal embolization from oa.
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Search Alerts/Recalls
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