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	12/17/2024
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 additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
A peripheral orbital atherectomy device (oad), viperwire advance peripheral guide wire, and a nav6 filter were used to treat a non-tortuous, severely calcified, severely stenosed lesion in the right popliteal.Following several treatments, the nav6 was attempted to be removed, however, was unable to be pulled back into the retrieval catheter pod.During removal of all the devices, the guide wire fractured.A pair of hemostats were used as a snare to remove the devices successfully.The patient was stable with no adverse effects.
Event or Problem Description
A peripheral orbital atherectomy device (oad), viperwire advance peripheral guide wire, and a nav6 filter were used to treat a non-tortuous, severely calcified, severely stenosed lesion in the right popliteal.Following several treatments, the nav6 was attempted to be removed, however, was unable to be pulled back into the retrieval catheter pod.During removal of all the devices, the guide wire fractured.A pair of hemostats were used as a snare to remove the devices successfully.The patient was stable with no adverse effects.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 - codes 4755, 4118, 3233, and 11 are no longer applicable.A visual inspection, and dimensional analysis were performed on the returned device.The reported material separation was confirmed.The reported complaint of unexpected medical intervention could not be confirmed through analysis due to the operational context of the issue.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.It was reported that the viperwire was used with a nav6 filter.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 reported information and the observations from the returned analysis, the investigation determined that the reported material separation, and unexpected medical intervention appears to be related to user error.The guide wire was returned with the spring tip fractured and a nav 6 retrieval catheter engaged on the distal fractured section.The damage is likely due to interaction with the nav 6 retrieval catheter during removal attempts.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.

• 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: 21118147
• Report Number: 3004742232-2025-00014
• Device Sequence Number: 12682643
• Product Code: MCW
• UDI-Device Identifier: 10852528005725
• UDI-Public: (01)10852528005725(17)260531(10)538219-2
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/26/2025

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: 05/31/2026
• Device Model Number: VPR-GW-FLEX18
• Device Catalogue Number: VPR-GW-FLEX18
• Device Lot Number: 538219-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 75 KG