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	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that abbott command wire was during procedure past superficial femoral artery (sfa) lesion and orbital atherectomy was performed without issues.Three treatments on low, medium and high speeds were performed.It was bidirection treatment.Armada18 balloon was loaded onto the viperwire peripheral guidewire for post dilation and upon armada balloon being deflated, it was noted the wire was missing and traveled down the leg a small way.The broken viperwire guidewire was successfully retrieved from the patient¿s leg by trapping it with a trek coronary balloon and removing the whole wire, balloon, and sheath.There were no adverse patient effects.It was noted that there was no wire bias and there is no indication on how the fracture occurred.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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.Detailed analysis of the wire found evidence that the fracture occurred during use in an elevated stress condition.Potential causes of elevated stress on the wire could be axial compression causing a buckled condition, or bends or kinks near the area of fracture.Spinning over these areas may lead to guide wire fracture.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.
Event or Problem Description
It was reported that abbott command wire was during procedure past superficial femoral artery (sfa) lesion and orbital atherectomy was performed without issues.Three treatments on low, medium and high speeds were performed.It was bidirection treatment.Armada18 balloon was loaded onto the viperwire peripheral guidewire for post dilation and upon armada balloon being deflated, it was noted the wire was missing and traveled down the leg a small way.The broken viperwire guidewire was successfully retrieved from the patient¿s leg by trapping it with a trek coronary balloon and removing the whole wire, balloon, and sheath.There were no adverse patient effects.It was noted that there was no wire bias and there is no indication on how the fracture occurred.

• 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, #3008814558; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 24272640
• Report Number: 3004742232-2026-00016
• Device Sequence Number: 18806209
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)270831(10)582940-1
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/03/2026

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 Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 582940-1
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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