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

Model Number	VPR-GW-FLEX14
Medical Device Problem Codes	Entrapment of Device (1212); Unintended System Motion (1430); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure to treat lesion in calcified, highly tortuous, 85% stenosed distal dorsalis pedis artery (dp), the 1.25 micro diamondback 360 exchangeable peripheral orbital atherectomy device (oad) shut off during first run.The vessel diameter was 2.00mm.The viperwire advance peripheral guide wire with flex tip was exchanged from a non-abbott wire.During removal, it was noted that the oad became entangled in the dissection flap.There was no dissection before the procedure.The dissection was not seen angiographically but the physician thought it was a small flap that the crown got stuck on.The oad and the viperwire could not be removed due to the viperwire being fractured and stuck in the vessel.A cut down procedure was performed for removal, and the physician was able to remove the crown, but the entire radiopaque section of the viperwire tip was left in the leg as there was no longer access to the vessel.Wire access was lost due to the viperwire being stuck in the vessel distal to the crown that was stuck in the vessel wall.The viperwire radiopaque tip was left in the foot and the cut down to remove the crown was sutured closed.The dissection was not treated.The entire vessel was pulled out with the crown.Upon removal, the oad crown was observed to be covered in tissue.The sales representative indicated that the patient would end up having a transmetatarsal amputation (tma) (partial toe amputation).The patient had a big toe amputation two days prior to the procedure.The patient was stable and discharged two days later.The physician thought the oad became stuck due to some sort of tissue flap that wasn't seen angiographically.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The orbital atherectomy device referenced in b5 is filed under a separate medwatch report number.
Additional Manufacturer Narrative
The device was not returned for 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 information received, the investigation determined that the reported material separation, entrapment of device, unintended system movement, foreign body in patient, surgical intervention, and hospitalization appear to be related to operational context.In this case, it is possible that the material separation, entrapment of device, unintended system movement, foreign body in patient, surgical intervention, and hospitalization are the result of the patient disease state and/or use techniques employed.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: b5, g3, g6, h2, h6.H6: codes 4118, 3233, and 11 no longer apply.H10: the orbital atherectomy device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that during procedure to treat lesion in calcified, highly tortuous, 85% stenosed distal dorsalis pedis artery (dp), the 1.25 micro diamondback 360 exchangeable peripheral orbital atherectomy device (oad) shut off during first run.The vessel diameter was 2.00mm.The viperwire advance peripheral guide wire with flex tip was exchanged from a non-abbott wire.During removal, it was noted that the oad became entangled in the dissection flap.There was no dissection before the procedure.The dissection was not seen angiographically but the physician thought it was a small flap that the crown got stuck on.The oad and the viperwire could not be removed due to the viperwire being fractured and stuck in the vessel.A cut down procedure was performed for removal, and the physician was able to remove the crown, but the entire radiopaque section of the viperwire tip was left in the leg as there was no longer access to the vessel.Wire access was lost due to the viperwire being stuck in the vessel distal to the crown that was stuck in the vessel wall.The viperwire radiopaque tip was left in the foot and the cut down to remove the crown was sutured closed.The dissection was not treated.The entire vessel was pulled out with the crown.Upon removal, the oad crown was observed to be covered in tissue.The sales representative indicated that the patient would end up having a transmetatarsal amputation (tma) (partial toe amputation).The patient had a big toe amputation 2 days prior to the procedure.The patient was stable and discharged two days later.The physician thought the oad became stuck due to some sort of tissue flap that wasn't seen angiographically.Subsequent to the previously filed report, additional information was received: the patient did receive the mid foot amputation, and all wounds have healed.Patient is at home and doing great according to the physician.

• 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: 23750456
• Report Number: 3004742232-2025-00368
• Device Sequence Number: 9583545
• 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,Followup
• Report Date (Section B): 01/12/2026

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: 576026-1
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Hispanic