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

Model Number	VPR-GW-14
Medical Device Problem Codes	Off-Label Use (1494); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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
A peripheral viperwire guide wire was inadvertently inserted into a coronary orbital atherectomy device.It was reported that the labeling on the wire packaging was not clear.An unusual sound was noted during testing, and during attempts to remove the oad from the guide wire the wire fractured in vivo.After over two hours of unsuccessful attempts to snare the wire, the fragment was stented against the vessel wall.The procedure was continued with a coronary guide wire and the patient was discharged the following day.
Additional Manufacturer Narrative
Csi id: (b)(6).

• 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: 11974385
• Report Number: 3004742232-2021-00212
• Device Sequence Number: 4015248
• Product Code: MCW
• UDI-Device Identifier: 10852528005077
• UDI-Public: (01)10852528005077(17)211031(10)299067
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 10/31/2021
• Device Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Device Lot Number: 299067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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: 78 YR
• Patient Weight: 91