Model Number DBP-200SOLID145 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Perforation of Vessels (2135); Embolism/Embolus (4438)
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Event Date 11/09/2023 |
Event Type
Injury
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Event Description
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A diamondback 360 peripheral orbital atherectomy device (oad) was used to treat a 90% stenosed, calcified lesion in the right proximal superficial femoral artery (sfa).After atherectomy, angiographic imaging revealed perforation and distal embolization.The patient was discharged home four days later.
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Manufacturer Narrative
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H6 investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for use manual states that perforation of vessels and distal embolization are potential adverse events 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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Event Description
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Additional information: there was no perforation.Patient hospitalization was due to family circumstances unrelated to the reported event.
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Manufacturer Narrative
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Corrections: h6 codes 2135 and 4607 were removed.Csi id: (b)(4).
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Search Alerts/Recalls
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