CARDIOVASCULAR SYSTEMS, INC. STEALTH PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE
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Model Number PRD-SC30-200 |
Device Problem
Mechanical Problem (1384)
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Patient Problems
Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Device analysis conclusion: the oad and guidewire were received at csi for analysis.The guidewire was not engaged in the device.There was a slight bend in the core shaft of the guidewire.The damage likely occurred during shipping.The damage was not considered a contributing factor in the reported complaint.There was no other visible damage, and there was no damage observed with the driveshaft or handle assembly that would have contributed to slow flow or the reported dissection.The device data log was reviewed, and a bog event was observed.A bog event indicates a drop in device speed.The cause of the bog event could not be determined through analysis; the oad functioned as intended during 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.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 stealth peripheral orbital atherectomy device (oad) was used for treatment of a 90% stenosed lesion in the superficial femoral artery (sfa).Multiple treatment passes were performed on all speeds.During pullback to the resting position, the oad slowed and stalled.Some resistance was encountered during removal of the oad.This was attributed to the 2mm crown size and bifurcation characteristics.Angiography then showed flow was sluggish, and there was no flow through the treated segment.Angioplasty was applied, but a significant dissection was noted.A stent was deployed over the treatment area, and flow was brisk thereafter.
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