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	Foreign Body In Patient (2687)
Date of Event	10/22/2024
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.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.
Event or Problem Description
It was reported that the procedure was performed to treat a 90% calcified left common femoral artery and 50%-70% diffused superficial femoral artery using an emboshield nav 6 filter with a 6f sheath and a viperwire advance guidewire.The nav 6 filter crossed the target lesion, however when retrieving the device, the tip of the guidewire broke off into two pieces and the guidewire about 1 cm in length remained in the patient.The wire tip was embedded in a branch post procedure.The emboshield nav 6 filter was removed with the sheath and in the physician's opinion, the patient will need additional intervention to retrieve the guide wire tip and does not have any concerns about potential long-term risk outcomes.Manual compression was held after removal of sheath with nav 6 filter and wire to complete the procedure.There was no clinically significant delay in the procedure and the patient was discharged home.
Event or Problem Description
It was reported that the procedure was performed to treat a 90% calcified left common femoral artery and 50%-70% diffused superficial femoral artery using an emboshield nav 6 filter with a 6f sheath and a viperwire advance guidewire.The nav 6 filter crossed the target lesion, however when retrieving the device, the tip of the guidewire broke off into two pieces and the guidewire about 1 cm in length remained in the patient.The wire tip was embedded in a branch post procedure.The emboshield nav 6 filter was removed with the sheath and in the physician's opinion, the patient will need additional intervention to retrieve the guide wire tip and does not have any concerns about potential long-term risk outcomes.Manual compression was held after removal of sheath with nav 6 filter and wire to complete the procedure.There was no clinically significant delay in the procedure and the patient was discharged home.
Additional Manufacturer Narrative
A visual inspection, functional testing, dimensional analysis was performed on the returned device.The guide wire fracture is not confirmed.There are no fractured observed.Per complaint details, the correct device was returned.The guide wire is kinked.Based on the information received, the investigation determined that the reported damage to the guide wire appears to be related to use inconsistent with the instructions for use.In this case, it is likely that the guide wire damage is 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.H6: codes 4755, 4118, 3233, and 11 no longer apply.The additional device referenced in b5 is filed under separate medwatch report number.

• 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: 20698710
• Report Number: 3004742232-2024-01004
• Device Sequence Number: 3850548
• Product Code: MCW
• UDI-Device Identifier: 10852528005084
• UDI-Public: (01)10852528005084(17)260131(10)529446-1
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 01/20/2025

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: 01/31/2026
• Device Model Number: VPR-GW-17
• Device Catalogue Number: VPR-GW-17
• Device Lot Number: 529446-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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: EMBOSHIELD NAV 6
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American