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

Model Number	VPR-GW-FLEX14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a peripheral orbital atherectomy device (oad) was used to treat a heavily calcified lesion in right proximal anterior tibial artery (at).After two low speed treatments and one medium speed treatment, the viperwire peripheral guide wire fractured in half and was successfully snared.There were no adverse patient effects and the procedure was delayed by 30-40 mins.This was not considered clinically significant delay.The procedure was completed using a non-abbott device, 2.5x240 jade balloon, and nc trek balloon to open up at.It was unknown how the guide wire fracture occurred.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported a peripheral orbital atherectomy device (oad) was used to treat a heavily calcified lesion in right proximal anterior tibial artery (at).After two low speed treatments and one medium speed treatment, the viperwire peripheral guide wire fractured in half and was successfully snared.There were no adverse patient effects and the procedure was delayed by 30-40 mins.This was not considered clinically significant delay.The procedure was completed using a non-abbott device, 2.5x240 jade balloon, and nc trek balloon to open up at.It was unknown how the guide wire fracture occurred.
Additional Manufacturer Narrative
A visual inspection, dimensional analysis and detailed analysis were performed on the returned device.The reported guide wire fracture 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 guide wire fracture appears to be related to circumstances of the procedure.There is rotational wear on the surface of the wire near the fracture site.Testing has shown that excessive wear between the guide wire and oad tip bushing may occur due to tortuosity, tight bends, and/or buckling of the guide wire due to being advanced forward against resistance which compresses the guide wire into a bent/buckled shape.It is hypothesized that the excessive wear led to the eventual fracture of the guide wire, although the exact root cause of fracture remains undetermined.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.H6: codes 4755, 4118, 3233, and 11 no longer apply.

• 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: 22309870
• Report Number: 3004742232-2025-00177
• Device Sequence Number: 12782992
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)251130(10)514944-1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/12/2025

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: 11/30/2025
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 514944-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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 Sex: Unknown