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); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
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 the intervention was to open the occluded left superficial femoral artery (sfa).A 7fr access in the right common femoral artery (cfa) with contralateral approach to the left cfa was performed.The lesion was crossed with two non-abbott catheters and one of the non-abbott catheter was exchanged for a.014/.018 viperwire advance guidewire.A 7.2mm emboshield nav6 was deployed in the mid popliteal artery.A 1.5 solid diamondback orbital atherectomy device (oad) was used to in the left sfa, followed by pta and dcb.Two low speed and two medium speed treatments were performed.When retrieval of the nav6 occurred, it was identified that the tip of the viperwire had separated, was coiled in a loop, and remained in the popliteal artery.After multiple attempts, retrieval of the wire tip was achieved with a snare with the use of a viperwire peripheral advance guidewire.There was no wire bias or difficulty delivering devices.The oad did not make contact with the viperwire spring tip, as there was a nav6 on the viperwire.The patient was in stable condition.
Additional Manufacturer Narrative
A visual inspection, dimensional analysis and detailed analysis were performed on the returned device.The reported guide wire fracture at the spring tip is 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.Detailed analysis of the fracture shows evidence that the wire was manipulated (bent, etc.) and pulled to failure.This may have occurred due to interaction with the nav 6 retrieval catheter during removal attempts.It should be noted that the viperwire instruction for use (ifu), in the indicated use and precaution and warnings sections, states: ¿the viperwire guide wire is intended for use with csi orbital atherectomy devices (oad), including the stealth 360°¿ and diamondback 360°®.¿ 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 4755, 4118, 3233, and 11 no longer apply due to additional information received.
Event or Problem Description
It was reported that the intervention was to open the occluded left superficial femoral artery (sfa).A 7fr access in the right common femoral artery (cfa) with contralateral approach to the left cfa was performed.The lesion was crossed with two non-abbott catheters and one of the non-abbott catheter was exchanged for a.014/.018 viperwire advance guidewire.A 7.2mm emboshield nav6 was deployed in the mid popliteal artery.A 1.5 solid diamondback orbital atherectomy device (oad) was used to in the left sfa, followed by pta and dcb.Two low speed and two medium speed treatments were performed.When retrieval of the nav6 occurred, it was identified that the tip of the viperwire had separated, was coiled in a loop, and remained in the popliteal artery.After multiple attempts, retrieval of the wire tip was achieved with a snare with the use of a viperwire peripheral advance guidewire.There was no wire bias or difficulty delivering devices.The oad did not make contact with the viperwire spring tip, as there was a nav6 on the viperwire.

• 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: 21663553
• Report Number: 3004742232-2025-00058
• Device Sequence Number: 7662567
• Product Code: MCW
• UDI-Device Identifier: 10852528005725
• UDI-Public: (01)10852528005725(17)250630(10)492673-1
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: VPR-GW-FLEX18
• Device Catalogue Number: 7-10041-04
• Device Lot Number: 492673-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White