MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED VIPERWIRE ADVANCE FLEXTIP; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	VPR-GW-FLEX18
Medical Device Problem Codes	Unintended System Motion (1430); Material Separation (1562); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The emboshield nav6 referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
Oa: it was reported an orbital atherectomy device (oad) was used to treat a popliteal artery, followed by a left superficial femoral artery (lsfa) and a tibioperoneal trunk (tpt) artery.As the oad was being backed out to treat another lesion, the oad pulled the viperwire guide wire, which dislodged the nav 6 filter.It was indicated the oad pulling the wire out of position was due to improper wire-pinning technique.The retrieval catheter was loaded on the guide wire but was unable to be advanced.The viperwire tip fractured and lodged within the nav 6 filter.The filter was pulled into the sheath.A sheath swap was performed, but the fractured component remained in-vivo, in an occluded vessel.A drug-coated balloon was used to complete the procedure.The patient was in stable condition.The physician had no concerns about long term consequences for the patient.In the physician's opinion, the component may have gotten stuck in the vessel leading to the fracture.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information received, the investigation determined that the reported material separation, foreign body in patient, unintended system movement and unexpected medical intervention appears to be related to operational context.In this case, it is possible that the material separation, foreign body in patient, unintended system movement and unexpected medical intervention is the result of use techniques employed or interaction with the nav6 filter.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Correction: b5 (removed "oa:") updated: h6 (codes 4118, 3233, and 11 no longer apply).
Event or Problem Description
It was reported an orbital atherectomy device (oad) was used to treat a popliteal artery, followed by a left superficial femoral artery (lsfa) and a tibioperoneal trunk (tpt) artery.As the oad was being backed out to treat another lesion, the oad pulled the viperwire guide wire, which dislodged the nav 6 filter.It was indicated the oad pulling the wire out of position was due to improper wire-pinning technique.The retrieval catheter was loaded on the guide wire, but was unable to be advanced.The viperwire tip fractured and lodged within the nav 6 filter.The filter was pulled into the sheath.A sheath swap was performed, but the fractured component remained in-vivo, in an occluded vessel.A drug-coated balloon was used to complete the procedure.The patient was in stable condition.The physician had no concerns about long term consequences for the patient.In the physician's opinion, the component may have gotten stuck in the vessel leading to the fracture.

• Brand Name: VIPERWIRE ADVANCE FLEXTIP
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED, #3004742232; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 22751515
• Report Number: 3004742232-2025-00232
• Device Sequence Number: 9558088
• Product Code: MCW
• UDI-Device Identifier: 10852528005725
• UDI-Public: (01)10852528005725(17)260228(10)529447-1
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K180416
• 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,Followup
• Report Date (Section B): 09/08/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: VPR-GW-FLEX18
• Device Catalogue Number: 7-10041-04
• Device Lot Number: 529447-1
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VIPERWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female