MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) VIPERWIRE ADVANCE FLEXTIP; PERIPHERAL ORBITAL ATHERECTOMY DEVICE

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	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A viperwire advance peripheral guide wire with flex tip was used for treatment of a heavily calcified, chronic total occlusion (cto), 5-6mm diameter lesion in superficial femoral artery (sfa) via right common femoral artery (cfa).A 6fr 45cm guiding sheath was in use.There was no difficulty wiring or delivering devices.After five to six treatments of the target lesion, the abbott nav6 filter was captured.While removing the filter halfway through the sheath a three-cm tip of the.018-inch viperwire fractured.The sheath was removed with the nav6 filter and the tip of the viperwire in the sheath.After sheath removal manual pressure was applied on the access site to obtain hemostasis.The patient was stable.
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).
Additional Manufacturer Narrative
The fractured guide wire spring tip was returned engaged in the abbott emboshield nav6 embolic protection system filter.The fracture was near the strain relief.Scanning electron microscopy (sem) analysis of the fracture face showed evidence of non-torsional ductile dimples indicating that the wire experienced stressed manipulation to failure.This is consistent with complaint details which indicate that while removing the filter halfway through the sheath a three-cm tip of the.018-inch viperwire fractured.It is hypothesized that the wire core was manipulated and stressed to failure during the removal attempts.Due to the use of the guide wire with the nav6 embolic protection system filter, the cause of the fracture was considered to be use not consistent with the instructions for use (ifu) user manual.The viperwire ifu states "the viperwire guide wire is intended for use with csi orbital atherectomy devices (oad), including the stealth 360°¿ and diamondback 360°®." the material inspection report for this guide wire lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Csi id: (b)(4).

• Brand Name: VIPERWIRE ADVANCE FLEXTIP
• Common Device Name: PERIPHERAL ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 20280917
• Report Number: 3004742232-2024-00339
• Device Sequence Number: 12626064
• Product Code: MCW
• UDI-Device Identifier: 10852528005725
• UDI-Public: (01)10852528005725(17)260531(10)538216-1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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?: Yes
• 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: 538216-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/23/2024
• 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
• Patient Sex: Unknown