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

Model Number	VPR-GW-FLEX14
Medical Device Problem Codes	Material Separation (1562); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	11/04/2025
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 a 1.25 solid diamondback peripheral orbital atherectomy device (oad) and a viperwire peripheral guidewire were used to treat the peroneal artery.The vessel was primarily wired with the viperwire guidewire.Approximately nine treatments were performed on low, medium, and high-speed.The oad made contact with the spring tip, resulting in a guide wire fracture.The entire radiopaque tip remains in vivo.There was no wire bias.An attempt was made to balloon the fragment to the wall but imaging did not show any movement of the fragment.In addition, persistent slow flow was observed.Nitroglycerin was administered.The patient was stable.The physician did not have any concerns about potential long-term risk outcomes.
Event or Problem Description
It was reported that a 1.25 solid diamondback peripheral orbital atherectomy device (oad) and a viperwire peripheral guidewire were used to treat the peroneal artery.The vessel was primarily wired with the viperwire guidewire.Approximately nine treatments were performed on low, medium, and high-speed.The oad made contact with the spring tip, resulting in a guide wire fracture.The entire radiopaque tip remains in vivo.There was no wire bias.An attempt was made to balloon the fragment to the wall but imaging did not show any movement of the fragment.In addition, persistent slow flow was observed.Nitroglycerin was administered.The patient was stable.The physician did not have any concerns about potential long-term risk outcomes.Additional information was received and in the opinion of the physician, the viperwire guidewire was the cause of the slow flow and flow was restored on its own.The patient's wounds were healing.
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, device damaged by another device, foreign body in patient, medication required, obstruction/occlusion, unexpected medical intervention appear to be related to user error.In this case, it is possible that the material separation, device damaged by another device, foreign body in patient, medication required, obstruction/occlusion, unexpected medical intervention are the result of device placement and/or use techniques employed.It was reported the oad made contact with the spring tip, resulting in a guide wire fracture.The diamondback 360 peripheral orbital atherectomy system instructions for use (ifu) 92-10017 revision c), warns: ¿never advance the orbiting crown to the point of contact with the guide wire spring tip or other distal device.The maximum travel of the crown advancer knob¿and therefore the shaft tip¿is 15 cm.Moving the crown advancer knob forward moves the shaft tip an equal distance toward the guide wire spring tip.When moving the crown advancer knob, make sure there is sufficient distance between the guide wire spring tip (or other distal device) and the distal end of the shaft (10 cm minimum).If the distance between the shaft tip and the guide wire spring tip (or other distal device) is insufficient, the shaft tip may damage the guide wire spring tip (or other distal device) and result in device or component dislodgement.Distal detachment and embolization may result.¿ 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 fields: b5, g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions) and h11.

• 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: 23597757
• Report Number: 3004742232-2025-00349
• Device Sequence Number: 9290467
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)270430(10)571097-1
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/23/2025

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-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 571097-1
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2025
• 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 Age: 83 YR
• Patient Sex: Male