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

Model Number	VPR-GW-FLEX14
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection and dimensional analysis were performed on the returned device.The reported spring tip damage was confirmed.The reported difficult removal could not be confirmed through analysis due to the operational context of the reported issue.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 spring tip damage appears to be related to circumstances of the procedure.The guide wire was returned without any missing segments.However, the strain relief coil is separated and unraveled from the adhesive bond and the proximal end is pulled distally toward the spring tip.There is no indication of a strain relief issue, but more of an applied force on the guide wire core in the strain relief section that surpassed the material strength, resulting in the unraveling.This is consistent with complaint details that state ¿the guidewire was forcefully removed and did not fracture, however, the spring tip was frayed.¿ 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 a viperwire peripheral flextip guidewire was used with a peripheral orbital atherectomy device (oad) to treat calcification diffused disease throughout the posterior tibial (pt) artery to the dorsalis pedis (dp).Eight treatments were performed in the pt on low speed, the viperwire guidewire crossed the ankle and the oad did not cross the ankle by physician's choice.It was noted that there was no issue with the oad.The physician purposely stayed away from that area due to anatomy and to keep plenty of space away from wire tip.The vessel was ballooned and there was difficulty during removal of the guidewire from the vessel after treatment.The guidewire was forcefully removed and did not fracture, however, the spring tip was frayed.It was noted that oad and guidewire did not make contact during the procedure.The physician suspected the issue was due to patient anatomy.It was noted that the issue with the guidewire happened in the foot where there was no prior treatment with oad or any ballooning.The patient was stable.Initial analysis of the returned viperwire peripheral guidewire indicated that the spring tip strain relief was unraveled but not detached or separated.

• 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: 24211821
• Report Number: 3004742232-2026-00009
• Device Sequence Number: 12133463
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)270630(10)576026-1
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 01/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 576026-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2025
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Hispanic