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

Model Number	VPR-GW-FLEX14
Medical Device Problem Codes	Off-Label Use (1494); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During procedure to treat 90% stenosed heavily calcified anterior tibial artery, two treatments were performed using a non-abbott atherectomy device.The vessel was primarily wired with a non-abbott guidewire and was then exchanged for a viperwire advance peripheral guidewire.During procedure, the tip of the viperwire peripheral guidewire broke off in the patient and full soft tip of the viper wire flex tip was left in-vivo.This occurred during an outpatient visit and the patient was sent home.On (b)(6) 2025, the patient was brought back and the wire fragment was successfully retrieved using snare.The patient was in stable condition and the physician does not have any concerns about potential long-term risk outcomes.Additional information received noted that the physician was aware the guidewire was being used against the instructions for use (ifu).
Additional Manufacturer Narrative
A visual inspection, dimensional analysis, and detailed analysis were performed on the returned device.The reported guide wire fracture is confirmed.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 reported information and the observations from the returned analysis, the investigation determined that the reported guide wire fracture appears to be related to user error.Detailed analysis of the fracture shows evidence that the wire was twisted to failure.It was reported that the guide wire was used with a revolution atherectomy device.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 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.
Additional Manufacturer Narrative
A visual inspection, dimensional analysis, and detailed analysis were performed on the returned device.The reported guide wire fracture is confirmed.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 reported information and the observations from the returned analysis, the investigation determined that the reported guide wire fracture appears to be related to user error.Detailed analysis of the fracture shows evidence that the wire was twisted to failure.It was reported that the guide wire was used with a revolution atherectomy device.It should be noted that the viperwire instruction for use (ifu) 90057-00 revision s, 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 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 fields: g3, g6, h2 correction: code 4438 removed, code 22 removed.
Event or Problem Description
During procedure to treat 90% stenosed heavily calcified anterior tibial artery, two treatments were performed using a non-abbott atherectomy device.The vessel was primarily wired with a non-abbott guidewire and was then exchanged for a viperwire advance peripheral guidewire.During procedure, the tip of the viperwire peripheral guidewire broke off in the patient and full soft tip of the viper wire flex tip was left in-vivo.This occurred during an outpatient visit and the patient was sent home.On (b)(6) 2025, the patient was brought back and the wire fragment was successfully retrieved using snare.The patient was in stable condition and the physician does not have any concerns about potential long-term risk outcomes.Additional information received noted that the physician was aware the guidewire was being used against the instructions for use (ifu).
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
During procedure to treat 90% stenosed heavily calcified anterior tibial artery, two treatments were performed using a non-abbott atherectomy device.The vessel was primarily wired with a non-abbott guidewire and was then exchanged for a viperwire advance guidewire.During procedure, the tip of the viperwire peripheral guidewire broke off in the patient and full soft tip of the viper wire flex tip was left in-vivo.This occurred during an outpatient visit and the patient was sent home.On (b)(6) 2025, the patient was brought back and the wire fragment was successfully retrieved using snare.The patient was in stable condition and the physician does not have any concerns about potential long-term risk outcomes.
Additional Manufacturer Narrative
A visual inspection, dimensional analysis, and detailed analysis were performed on the returned device.The reported guide wire fracture is confirmed.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 reported information and the observations from the returned analysis, the investigation determined that the reported guide wire fracture appears to be related to user error.Detailed analysis of the fracture shows evidence that the wire was twisted to failure.It was reported that the guide wire was used with a revolution atherectomy device.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 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
During procedure to treat 90% stenosed heavily calcified anterior tibial artery, two treatments were performed using a non-abbott atherectomy device.The vessel was primarily wired with a non-abbott guidewire and was then exchanged for a viperwire advance peripheral guidewire.During procedure, the tip of the viperwire peripheral guidewire broke off in the patient and full soft tip of the viper wire flex tip was left in-vivo.This occurred during an outpatient visit and the patient was sent home.On (b)(6), 2025, the patient was brought back and the wire fragment was successfully retrieved using snare.The patient was in stable condition and the physician does not have any concerns about potential long-term risk outcomes.Additional information received noted that the physician was aware the guidewire was being used against the instructions for use (ifu).

• 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: 21865866
• Report Number: 3004742232-2025-00094
• Device Sequence Number: 11941966
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)261130(10)557814-1
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup,Followup
• Report Date (Section B): 06/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 557814-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 06/04/2025; 06/12/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/23/2025; 06/05/2025; 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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; Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American