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	11/28/2025
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 after removing the diamondback 360 peripheral orbital atherectomy device (oad), the tip of the viperwire advance peripheral guide wire with flex tip remained in the patient.Snare was used to remove the tip of the viperwire.
Event or Problem Description
It was reported that after removing the diamondback 360 peripheral orbital atherectomy device (oad), the tip of the viperwire advance peripheral guide wire with flex tip remained in the patient.Snare was used to remove the tip of the viperwire.
Additional Manufacturer Narrative
A visual inspection, functional testing, dimensional analysis and detailed analysis were performed on the returned device.The reported material separation 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 material separation appears to be related to user error.The guide wire was returned fractured 5.5cm from the distal end.Both segments were returned for analysis.Scanning electron microscopy (sem) analysis of the fracture site shows evidence of fatigue failure and a kink at the fracture site.The presence of a kink at the fracture site along with fatigue striations indicate that the wire was spun over after it was kinked.The diamondback 360 peripheral orbital atherectomy system (oas) instruction for use (ifu), cautions: ¿do not operate the oad if there is a bend, kink, or tight loop in the guide wire.A bend, kink, or tight loop in the guide wire may cause damage to and malfunctioning of the oad during use.¿ 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: g3, g6, h2, h3, h6 (codes 4755, 4118, 3233, and 11 no longer apply).

• 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: 23867125
• Report Number: 3004742232-2025-00376
• Device Sequence Number: 4605286
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)261130(10)557813-1
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 557813-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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