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

Model Number	VPR-GW-FLEX18
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A viperwire guide wire was advanced past the popliteal artery, and a non-csi filter was deployed over the wire.Atherectomy was performed in the left distal superficial femoral artery (sfa) with a diamondback peripheral orbital atherectomy device (oad) which was then removed.The lesion was approximately 100mm in length, heavily calcified, and exhibited at least 4 mm of calcium.An angioplasty balloon was placed and inflated to nominal pressure and removed.A drug coated balloon (dcb) was then inserted over the wire, inflated for three minutes, and removed.A stent was then deployed in the popliteal vessel.Simultaneously, while the stent was being deployed, the filter pulled back, though both appeared intact.A non-csi balloon, that was not inflated, was then used to attempt to reposition the filter distal to the stent.The tip of the viperwire was then observed to have fractured.An attempt was made to retrieve the viperwire tip with the filter.The filter basket was retrieved, but the fragment remained in vivo.A snare was then used to capture the fragment from the tibioperoneal (tp) trunk.
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 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.Csi id: (b)(4).

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 13978195
• Report Number: 3004742232-2022-00084
• Device Sequence Number: 12151169
• Product Code: MCW
• UDI-Device Identifier: 10852528005725
• UDI-Public: (01)10852528005725(17)231130(10)411221-1
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: VPR-GW-FLEX18
• Device Catalogue Number: 7-10041-04
• Device Lot Number: 411221-1
• 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: 03/09/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White