CARDIOVASCULAR SYSTEMS, INC. STEALTH ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE
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Model Number PRD-SC30-125 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 04/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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Race was indicated as "other." return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.(b)(4).
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Event Description
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The stealth orbital atherectomy device (oad) was used for treatment of lesions in the superficial femoral artery and anterior tibial artery (at).During treatment in the at, the device stalled and became stuck in the vessel.Unsuccessful attempts to remove the device included angioplasty, alternate access, and snares.The driveshaft of the oad was cut, and a sheath was advanced over the driveshaft, but the device could not be removed.The patient was then taken by ambulance to a hospital, and surgical removal was successfully performed.
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Manufacturer Narrative
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Device analysis conclusion: the oad handle was returned to csi with a portion of the driveshaft still intact.The remainder of the driveshaft was not returned, which is consistent with the details reported to csi.Review of the device data log revealed stall events during the procedure.It is possible that the stall events are related to the report that the oad became stuck in the vessel; however, this could not be confirmed through analysis.The cause of the stall events remains unknown.The oad operated as intended during functional testing.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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