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

Model Number	VPR-GW-14
Medical Device Problem Codes	Entrapment of Device (1212); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/02/2026
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.
Event or Problem Description
It was reported that the procedure was to treat the moderately calcified, non-tortuous, 80% stenosed right peroneal artery and moderately calcified, non-tortuous, 95% stenosed anterior tibial artery (at).A 5 fr non-abbott sheath was in use.A lesion in the peroneal has been successfully treated with the oad.The physician planned to treat the at, but the x-ray machine went down.The x-ray was rebooted.Angiographic images revealed the viperwire advance peripheral guide wire was bent in multiple places.It was unknown what led to the viperwire damage.The viperwire was so bent they could not get it back through the sheath to remove it.Another unspecified wire was used and withdrew the sheath and viperwire together but as it was coming out of the body the viperwire could not get through and got caught in the common femoral artery (cfa) arterial wall.The sheath was removed.A 5fr non-abbott dilator was used to remove the viperwire; the stiffness of the dilator helped straighten the kink to allow removal.A second viperwire was inserted to continue treatment, but the x-ray machine died again.The procedure was aborted due to the x-ray failing continuously.The patient was stable.It was unknown what led to the viperwire kink.
Event or Problem Description
It was reported that the procedure was to treat the moderately calcified, non-tortuous, 80% stenosed right peroneal artery and moderately calcified, non-tortuous, 95% stenosed anterior tibial artery (at).A 5 fr non-abbott sheath was in use.A lesion in the peroneal has been successfully treated with the oad.The physician planned to treat the at, but the x-ray machine went down.The x-ray was rebooted.Angiographic images revealed the viperwire advance peripheral guide wire was bent in multiple places.It was unknown what led to the viperwire damage.The viperwire was so bent they could not get it back through the sheath to remove it.Another unspecified wire was used and withdrew the sheath and viperwire together but as it was coming out of the body the viperwire could not get through and got caught in the common femoral artery (cfa) arterial wall.The sheath was removed.A 5fr non-abbott dilator was used to remove the viperwire; the stiffness of the dilator helped straighten the kink to allow removal.A second viperwire was inserted to continue treatment, but the x-ray machine died again.The procedure was aborted due to the x-ray failing continuously.The patient was stable.It was unknown what led to the viperwire kink.
Additional Manufacturer Narrative
A visual inspection, and dimensional analysis were performed on the returned device.The reported deformation due to compressive stress was confirmed.The reported entrapment of device and device embedded in tissue or plaque could not be confirmed through 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 reported information and the observations from the returned analysis, the investigation determined that the reported deformation due to compressive stress appears to be related to circumstances of the procedure.The guide wire was returned intact.There is a kink just proximal to the spring tip followed by a bent shape for approximately 20cm.There is also a kink 75.5cm from the proximal end.The cause of the damage is unknown.The relationship between the guide wire kinks and the reported entrapment of device and device embedded in tissue or plaque (if any) remains unknown.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: d9, h3, h6 (codes 4755, 4118, 3233, and 11 no longer apply).

• Brand Name: VIPERWIRE, ADVANCE
• 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; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 24421720
• Report Number: 3004742232-2026-00036
• Device Sequence Number: 21484895
• Product Code: MCW
• UDI-Device Identifier: 10852528005077
• UDI-Public: (01)10852528005077(17)270930(10)586997-1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/24/2026

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-14
• Device Catalogue Number: 72023-01
• Device Lot Number: 586997-1
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2025
• 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