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

Model Number	VPR-GW-FLEX14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure to treat 99% stenosed, heavily calcified, mildly tortuous popliteal superficial femoral artery (sfa) with 7fr sheath right groin access, a 1.5 solid diamondback peripheral orbital atherectomy device (oad) was used with viperwire guidewire.It was noted that there was no wire bias and the vessel was not primarily wired with viperwire guidewire and was exchanged.During removal of the catheter, the guidewire spring tip broke off as it was stuck on calcium.About 3 cm in length of the guidewire spring tip was snared.A non-abbott balloon was used to successfully complete the procedure.The patient was stable.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection, dimensional analysis and detailed analysis were performed on the returned device.The reported guide wire fracture was confirmed.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 guide wire fracture appears to be related to user error.Analysis found evidence that the driveshaft was spinning too close to the spring tip (fracture was 6cm from the distal end and shows fatigue).The peripheral oas instruction for use (ifu), 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: g3, g6, h2, h3, h6 (component code, type of investigation, investigation findings, investigation conclusions) and h11.
Event or Problem Description
It was reported that during procedure to treat 99% stenosed, heavily calcified, mildly tortuous popliteal superficial femoral artery (sfa) with 7fr sheath right groin access, a 1.5 solid diamondback peripheral orbital atherectomy device (oad) was used with viperwire guidewire.It was noted that there was no wire bias and the vessel was not primarily wired with viperwire guidewire, it was exchanged.During removal of the catheter, the guidewire tip broke off as it was stuck on calcium.The radio opaque tip of the wire about 3 cm in length was snared.A non-abbott balloon was used to successfully complete the procedure.The patient was stable.

• 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: 23485699
• Report Number: 3004742232-2025-00334
• Device Sequence Number: 18699103
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 78 YR
• Patient Sex: Male