CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; 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 Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/20/2023 |
Event Type
Injury
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Event Description
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After treatment with the diamondback 360 peripheral orbital atherectomy device (oad), angiographic imaging showed slow flow.Arterial infusion of alprostadil was performed after aspiration with a thrombus aspiration catheter.No thrombus was observed, and the procedure was successfully completed with balloon angioplasty.
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Manufacturer Narrative
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H6 health effect - clinical code 4581: slow/no flow.H6 investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for use manual states that slow or no flow phenomenon is a potential adverse event that may occur and/or require intervention with use of the system.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).
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