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

Model Number	VPR-GW-FLEX18
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
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 guidewire 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 viperwire guidewire and orbital atherectomy device (oad) were used for treatment of a severely calcified lesion in the anterior tibial artery via femoral antegrade approach.The vessel was not tortuous, and the diameter wsa 2.5mm.The lesion was a chronic total occlusion.The wire fractured during wire exchange prior to atherectomy.The physician was able to remove the wire tip with use of the catheter.A 4fr sheath was advanced over the wire fragment and catheter, and the sheath was retracted.Treatment was completed thereafter.

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE (GUIDEWIRE)
• 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: 14187395
• Report Number: 3004742232-2022-00103
• Device Sequence Number: 4297742
• Product Code: MCW
• UDI-Device Identifier: 10852528005725
• UDI-Public: (01)10852528005725(17)231231(10)414345-1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/22/2022

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: 12/31/2023
• Device Model Number: VPR-GW-FLEX18
• Device Catalogue Number: 7-10041-04
• Device Lot Number: 414345-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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: 88 YR
• Patient Sex: Male
• Patient Race: White