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	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The guide wire was received at csi for analysis.Visual examination revealed the guide wire was fractured, and that the spring tip was intact with no damage observed.Scanning electron microscopy analysis revealed evidence of fatigue and a large crack down the middle of the guide wire, which was consistent with a fracture due to use of the wire in an unusually elevated stress environment.At the conclusion of the device analysis investigation, the report that the guide wire had fractured was confirmed, however the exact 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.(b)(4).
Event or Problem Description
Orbital atherectomy treatment was successfully performed in the superficial femoral artery, and the peripheral orbital atherectomy device was removed from the patient.Multiple balloons were inserted over the viperwire guide wire and balloon angioplasty was performed.The balloons and wire were removed from the patient.An angiogram was performed and revealed that part of the guide wire had fractured and remained in the sheath.The fragment was retrieved from the sheath with a snare device.The patient condition following the procedure was described as "fine.".

• 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: 11064551
• Report Number: 3004742232-2020-00417
• Device Sequence Number: 19472917
• Product Code: MCW
• UDI-Device Identifier: 10852528005077
• UDI-Public: (01)10852528005077(17)220430(10)328047
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/23/2020

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: 04/30/2022
• Device Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Device Lot Number: 328047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/23/2020
• 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: Required Intervention