CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE
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Model Number DBP-200SOLID145 |
Device Problem
Entrapment of Device (1212)
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Patient Problems
Tissue Damage (2104); Vascular System (Circulation), Impaired (2572); Vascular Dissection (3160)
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Event Date 05/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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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 the reported oad was unable to be reviewed, as the lot number was not provided.If the lot number is provided, a dhr review will be performed.Csi id: (b)(6).
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Event Description
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A diamondback peripheral orbital atherectomy device (oad) was selected for treatment of a lesion in the right distal superior femoral artery (sfa).The lesion was 80 to 90% stenosed, 40-50mm in length, and was mildly to moderately calcified.Access was obtained in the left common femoral artery, and the reference vessel was about 6mm in diameter.Two treatments were administered on low, medium, and high speed.The user noted a dull sound while spinning, but the device was deemed safe for continued use.Following treatment, the oad could not be removed through the 6fr sheath.Imaging was performed, and haziness was noted around the device.A large flow-limiting dissection was identified at the level of the lesion.A second wire was inserted to maintain position, and the oad, guide wire, and sheath were removed together.A new 6fr sheath was inserted, and a stent was deployed to resolve the dissection.Angiography showed the stent had covered the dissection.Brisk, timi 3 flow was noted in the right sfa and runoff vessels.Angiography was then performed for the left common femoral access site, and a large hazy image was noted at the bifurcation of the left sfa and profunda.The physician hypothesized that the hazy image was tissue which may have come off during removal of the oad.Surgical cut down was performed, and large pieces of tissue were removed.Brisk flow was reestablished to the left leg.The following day, the patient was well with bounding pulses in both legs and was expected to be discharged home.
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Manufacturer Narrative
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The reported guide wire was returned at csi for analysis, without the spring tip.Visual examination confirmed a fracture on the core shaft.Scanning electron microscopy of the guide wire revealed evidence of torsional dimples and rotational wear near the fracture.The surface wear was the result of use in an elevated stress environment and was consistent with the oad spinning in a tight bend, but not traversing, resulting in excessive wear on the guide wire.At the conclusion of the device analysis investigation, the reported event was confirmed, however the root cause could not be determined.The material inspection report for this guide wire 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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Manufacturer Narrative
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The previous follow-up report (3004742232-2020-00171-001) was submitted inadvertently under the incorrect report number.No follow-up report is intended for csi id (b)(4).This report is intended to correct that error.The correct follow-up report number for csi id (b)(4) will be submitted under mdr 3004742232-2020-00177-001.
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