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

Model Number	VPR-GW-14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.The production records for this product could not be reviewed and a similar complaint query could not be performed because the part number and/or lot number was not reported, and the device was not returned.Based on the information received, the investigation determined that the reported material separation appears to be related to operational context.In this case, it is possible that the material separation is due to device placement or use techniques employed; however, since the device was not returned this could not be confirmed.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 a stealth 360 peripheral orbital atherectomy device (oad) was used to treat a tibioperoneal trunk (tp), popliteal artery, and mid superficial femoral artery (sfa).After four treatments, the patient lifted their leg and flexed their hip, resulting in viperwire guide wire wire bias.The oad was powered off.The oad was being removed with great resistance, thus the physician decided to remove the oad and viperwire together.Ex-vivo it was determined the viperwire fractured and 80 centimeters remained in the sfa and migrated to the peroneal artery.The fractured component was able to be retrieved.There were no patient complications as a result of the event.The patient was in stable condition.The cause of the fracture was determined to be due to the patient movement.

• 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, #3008814558; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 22992186
• Report Number: 3004742232-2025-00260
• Device Sequence Number: 13011087
• Product Code: MCW
• UDI-Device Identifier: 10852528005077
• UDI-Public: (01)10852528005077(17)270331(10)571093-1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/08/2025

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 Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Device Lot Number: 571093-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2025
• 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