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

Model Number	VPR-GW-FLEX18
Medical Device Problem Codes	Difficult to Remove (1528); Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the common femoral artery (cfa) with heavy calcification and the superficial femoral artery (sfa).The emboshield nav 6 embolic protection system (eps) was deployed with a viperwire guide wire and used in the procedure.Upon retrieval, the filter was able to be collapsed but only halfway due to too much debris and the wire, catheter and filter could not be pulled in the 6french (f) sheath.Forward force on the catheter was applied.The wire was pulled backwards and removed but the filter was sheared off.A portion of the filter was removed but the distal tip snapped off during retrieval.Attempted to aspirate the tip but unsuccessful.Fluoroscopy showed the tip started traveling and lodged in the anterior tibial (at).The physician was able to wire the at and a non-abbott stent was implanted to embed the separated tip and filter on the wall of the vessel.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The nav 6 filter referenced in b5 is filed under a separate medwatch report number.D4: the udi number is not known as the part and lot number were not provided.
Additional Manufacturer Narrative
A visual inspection, functional testing and dimensional analysis were performed on the returned device.The reported difficult to remove was confirmed.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 reported information and the observations from the returned analysis, the investigation determined that the reported difficult to remove appears to be related to circumstances of the procedure.The guide wire was returned engaged in a nav6 catheter.The guide wire is fully intact with the distal spring tip seized within the nav6 filter.The guide wire spring tip was removed from the filter with resistance.It is possible that the incompatibility between the viperwire and the nav 6 contributed to the reported difficult to remove and damage to the nav 6.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.Updated: d4, h2, h3, h6 (codes 4755, 4118, 3233, and 11 no longer apply).
Event or Problem Description
It was reported that the procedure was to treat a lesion in the common femoral artery (cfa) with heavy calcification and the superficial femoral artery (sfa).The emboshield nav 6 embolic protection system (eps) was deployed with a viperwire and used in the procedure.Upon retrieval, the filter was able to be collapsed but only halfway due to too much debris and the wire, catheter and filter could not be pulled in the 6french (f) sheath.Forward force on the catheter was applied.The wire was pulled backwards and removed but the distal tip snapped off.Attempted to aspirate the tip but unsuccessful.Fluoroscopy showed the tip started traveling and lodged in the anterior tibial (at).The physician was able to wire the at and a non-abbott stent was implanted to embed the separated tip on the wall of the vessel.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.

• 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: 23327217
• Report Number: 3004742232-2025-00307
• Device Sequence Number: 10612366
• Product Code: MCW
• UDI-Device Identifier: 10852528005725
• UDI-Public: (01)10852528005725(17)260531(10)538219-1
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: VPR-GW-FLEX18
• Device Catalogue Number: 7-10041-04
• Device Lot Number: 538219-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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: 6FRENCH SHEATH ANSEL
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 91 KG