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

Model Number	VPR-GW-FLEX14
Medical Device Problem Codes	Unintended System Motion (1430); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The first viperwire guide wire referenced in b5 is filed under a separate medwatch number.
Event or Problem Description
It was reported that the target lesion was in superficial femoral artery (sfa) which was mildly calcified and non-tortuous.During advancement of the 5.0mm x 40mm jade.014" otw 150cm over the.014 viperwire advance peripheral guide wire with flex tip through a 6f non-abbott sheath, the balloon was sticking to the viperwire and pulled it out of position.Antegrade femoral artery approach was used which was noted to have a sharp bend.A new viperwire was used, and the same jade balloon was then attempted to be advanced with the same sticking encountered.The viperwire, jade balloon and sheath were all removed from the patient where it was identified both viperwires and the sheath were kinked.The viperwires were kinked one third down the wire and the sheath was kinked about 30cm proximal.A new sheath, jade balloon and abbott command wire were used to successfully complete the procedure.There was no delay or adverse patient effects reported.The viperwires and jade balloon were prepared according to instructions for use (ifu) instructions and the viperwires were wetted throughout use.It is believed the 6f sheath became kinked due the sharp bend in the access site and caused the issues.
Event or Problem Description
It was reported that the target lesion was in superficial femoral artery (sfa) which was mildly calcified and non-tortuous.During advancement of the 5.0mm x 40mm jade.014" otw 150cm over the.014 viperwire advance peripheral guide wire with flex tip through a 6f non-abbott sheath, the balloon was sticking to the viperwire and pulled it out of position.Antegrade femoral artery approach was used which was noted to have a sharp bend.A new viperwire was used, and the same jade balloon was then attempted to be advanced with the same sticking encountered.The viperwire, jade balloon and sheath were all removed from the patient where it was identified both viperwires and the sheath were kinked.The viperwires were kinked one third down the wire and the sheath was kinked about 30cm proximal.A new sheath, jade balloon and abbott command wire were used to successfully complete the procedure.There was no delay or adverse patient effects reported.The viperwires and jade balloon were prepared according to instructions for use (ifu) instructions and the viperwires were wetted throughout use.It was believed the 6f sheath became kinked due the sharp bend in the access site and caused the issues.
Additional Manufacturer Narrative
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 provided, a definitive cause for the reported difficult to advance, unintended system movement and deformation due to compressive stress could not be determined.In this case, it is likely that the difficult to advance, unintended system movement and deformation due to compressive stress is due to damage to the guidewire or accessory support device; however, since the device was not returned this could not be confirmed.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.Updated: g3, g6, h2, h6.H6: codes 4118, 3233, and 11 no longer apply.H10: the first viperwire guide wire referenced in b5 is filed under the medwatch number.

• 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: 21841941
• Report Number: 3004742232-2025-00087
• Device Sequence Number: 8816867
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)261031(10)554915-1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/19/2025

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 Model Number: VPR-GW-FLEX14
• Device Catalogue Number: VPR-GW-FLEX14
• Device Lot Number: 554915-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2024
• 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: Male
• Patient Weight: 102 KG