Model Number DBP-200SOLID145 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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.Csi id: (b)(4).
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Event Description
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Following treatment in the superficial femoral artery, the diamondback 360 peripheral orbital atherectomy device (oad) became stuck in the vessel upon removal.The oad was turned on and pulled retrograde.The patient was stable with no consequences.
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Manufacturer Narrative
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Results code: 4247 - suggested code is biological material present on device.A section of driveshaft 16.1cm long was returned to csi without the oad.Scanning electron microscopic testing was performed and confirmed the driveshaft was cut.Biological material accumulation was observed on the distal edge of the crown which was not considered to be a contributing factor in the reported complaint.No damage or abnormalities were observed on the driveshaft or crown that would have contributed to the reported event.As the non-csi sheath was not returned, it could not be determined if it was damaged or contributed to the reported complaint.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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Search Alerts/Recalls
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