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

Model Number	VPR-GW-FLEX18
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Deformation Due to Compressive Stress (2889); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
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, foreign body in patient, difficult to remove, deformation due to compressive stress, and unexpected medical intervention appears to be related to operational context.In this case, it is likely that the material separation, foreign body in patient, difficult to remove, deformation due to compressive stress, and unexpected medical intervention is the result of use techniques employed or interaction with the nav6 filter.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 2.0 peripheral orbital atherectomy device (oad) was being used to treat the superficial femoral artery (sfa).After treatment, it was observed the viperwire guide wire was kinked proximal to the oad handle.This made it difficult to remove the oad from the guide wire.The entire system, including a nav 6 filter, was removed together.Upon removal of the system, the physician noticed the guide wire full coil was detached and in the patient's posterior tibial artery (pt).It was unclear what led to the fracture.The physician entrapped the fractured component with a esprit btk scaffold 3.0 x 38 then post dilated with a 3.5 x 20 nc balloon.The patient was in stable condition.

• 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, #3004742232; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 22072019
• Report Number: 3004742232-2025-00147
• Device Sequence Number: 15586061
• Product Code: MCW
• UDI-Device Identifier: 10852528005725
• UDI-Public: (01)10852528005725(17)251031(10)512145-1
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/22/2025

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 Expiration Date: 10/31/2025
• Device Model Number: VPR-GW-FLEX18
• Device Catalogue Number: 7-10041-04
• Device Lot Number: 512145-1
• 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: 05/02/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2023
• 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