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

Model Number	VPR-GW-17
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	10/15/2024
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.
Event or Problem Description
It was reported a viperwire advance peripheral guide wire was used for treatment of calcified lesion in superficial femoral artery (sfa).The abbott emboshield nav6 embolic protection system was positioned in popliteal and used with the viperwire.Following five orbital atherectomy treatments, the tip of the viperwire fractured upon retrieval of the nav6 filter.The viperwire tip was successfully snared.The patient was stable and discharged home without further complication.
Event or Problem Description
It was reported a viperwire advance peripheral guide wire was used for treatment of calcified lesion in superficial femoral artery (sfa).The abbott emboshield nav6 embolic protection system was positioned in popliteal and used with the viperwire.Following five csi atherectomy treatments, the tip of the viperwire fractured upon retrieval of the nav6 filter.The viperwire tip was successfully snared.The patient was stable and discharged home without further complication.
Additional Manufacturer Narrative
Variance permits numbering sequence to deviate from the definition of a manufacturer report number found in 21 cfr part 803.3 (m)(3), to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.
Additional Manufacturer Narrative
Variance permits numbering sequence to deviate from the definition of a manufacturer report number found in 21 cfr part 803.3 (m)(3), to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 guide wire fracture appears to be related to operational context.In this case, it is likely that the distal guide wire was fractured as a result of use or handling techniques employed as well as 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 viperwire advance peripheral guide wire was used for treatment of calcified lesion in superficial femoral artery (sfa).The abbott emboshield nav6 embolic protection system was positioned in popliteal and used with the viperwire.Following five orbital atherectomy treatments, the tip of the viperwire fractured upon retrieval of the nav6 filter.The viperwire tip was successfully snared.The patient was stable and discharged home without further complication.

• Brand Name: VIPERWIRE, ADVANCE
• 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: 20642209
• Report Number: 3004742232-2024-01001
• Device Sequence Number: 7423062
• Product Code: MCW
• UDI-Device Identifier: 10852528005084
• UDI-Public: (01)10852528005084(17)251031(10)515963-1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K180416
• Exemption Number: GEN2400518
• 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,Followup
• Report Date (Section B): 12/13/2024

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: 10/31/2025
• Device Model Number: VPR-GW-17
• Device Catalogue Number: VPR-GW-17
• Device Lot Number: 515963-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 11/08/2024; 11/20/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 11/11/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown