MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number	VPR-GW-14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported guide wire was received at csi for analysis.A visual examination confirmed that both the distal section and the spring tip solder bond were fractured, and that the spring tip solder bond was damaged.Scanning electron microscopy analysis showed evidence of fatigue, without any indication of excessive wear on the surface of the wire.Analysis determined that this was due to an extreme and abnormal stress condition, however the cause of this condition was not identified.At the conclusion of the device analysis investigation, the report that the guide wire fractured was confirmed, although the root cause of the fractures 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).
Event or Problem Description
The diamondback peripheral orbital atherectomy device (oad) was operated for ten treatment passes without issue.After removal of the viperwire guide wire, it was observed that a portion of the guide wire remained in the patient.A snare device was used to retrieve the fragment, however part of the wire tip could not be retrieved and it was left in vivo.The patient was reported to be in stable condition.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 12091601
• Report Number: 3004742232-2021-00242
• Device Sequence Number: 19833602
• Product Code: MCW
• UDI-Device Identifier: 10852528005077
• UDI-Public: (01)10852528005077(17)210630(10)279597
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Device Lot Number: 279597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Weight: 127