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

Model Number	VPR-GW-FLEX18
Medical Device Problem Codes	Material Separation (1562); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/02/2025
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.The nav6 referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery (sfa).A 190cm emboshield nav 6 embolic protection system (eps) was advanced through resistance; however was noted to fail to deploy the filtration element and during removal resistance was felt and the distal end of the.018 viperwire guide wire was noted to separate near the distal end of the 6f sheath after force was applied.After the eps was completely removed an attempt to snare the separated viperwire was made; however was noted to be unsuccessful.Therefore the separate piece was surgically removed on the same day.It was unknown how the fracture occurred as the guide wire was fractured by the time force was applied during removal.There were no adverse patient effect nor clinical delay.
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, surgical intervention, and unexpected medical intervention appears to be related to user error.In this case, it is likely that the material separation, foreign body in patient, surgical intervention, 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.H6: codes 4118, 3233, and 11 no longer apply.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery (sfa).A 190cm emboshield nav 6 embolic protection system (eps) was advanced through resistance; however, was noted to fail to deploy the filtration element and during removal resistance was felt and the distal end of the.018 viper wire was noted to separate near the distal end of the 6f sheath after force was applied.After the eps was completely removed an attempt to snare the separated viper wire was made; however, was noted to be unsuccessful.Therefore, the separate piece was surgically removed on the same day.It was unknown how the fracture occurred as the guide wire was fractured by the time force was applied during removal.There were no adverse patient effect nor clinically significant delay.

• 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: 21875444
• Report Number: 3004742232-2025-00097
• Device Sequence Number: 18108988
• Product Code: MCW
• UDI-Device Identifier: 10852528005725
• UDI-Public: (01)10852528005725(17)260531(10)538219-1
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/28/2025

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: 05/31/2026
• Device Model Number: VPR-GW-FLEX18
• Device Catalogue Number: 7-10041-04
• Device Lot Number: 538219-1
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 6F.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 69 KG