MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number	DBP-200SOLID145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A diamondback gen 2 peripheral orbital atherectomy device (oad) was used for treatment of a lesion in the common femoral artery (cfa) via contralateral access.Tortuosity was minimal, and the lesion was heavily calcified.The stenosis extended into the superficial femoral artery, which was chronically occluded; there was pre-existing no flow after the cfa and profunda.Stenosis was 90%.Two low-speed treatments were performed, followed by two medium-speed treatments, and a high-speed treatment.During the second high-speed treatment, an unexpected audible noise was observed, and the oad became stuck on the guidewire.At this time the physician was not sure if the oad was stuck on the wire or stuck in a dissection plane.The physician was able to remove the oad and wire together, and it was then noted the wire had fractured and the fragment remained in the tip bushing of the oad.The vessel was rewired, and the procedure was completed with angioplasty.The physician was confident there were no fragments left in vivo.Device analysis determined the fractured component was a driveshaft filar as opposed to a guidewire.
Additional Manufacturer Narrative
Device analysis conclusion: the oad and wire were received at csi for analysis.The guidewire was engaged in the oad.There was no damage observed to the core shaft or spring tip of the guidewire despite the original information reported to csi.Analysis of the oad revealed a driveshaft filar fracture.The fracture occurred underneath the saline sheath, thereby causing damage and separation of the sheath.The fractured driveshaft filar prevented the guidewire from being removed, which confirmed the report that the oad had become stuck on the wire during the procedure.It should be noted that the fractured driveshaft filar is similar in appearance to a fractured guide wire core, which could explain why the customer mistakenly reported a guide wire fracture.Review of the device data log identified a stall event near the end of the procedure.It is unknown if this is related to the reported complaint.Scanning electron microscopy analysis of the fractured filar faces identified evidence of fatigue.It is hypothesized that a compressive force or tight bend radius was applied to the sheath while spinning, which caused an elevated stress environment resulting in the eventual driveshaft damage.Although this could not be confirmed, and the root cause of the damage remains unknown.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.(b)(4).

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 13966411
• Report Number: 3004742232-2022-00086
• Device Sequence Number: 11808865
• Product Code: MCW
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)230430(10)378938-1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 378938-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Unknown
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White