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

Model Number	VPR-GW-EL14
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure to treat moderately calcified, non-tortuous, 99% stenosed anterior tibial artery (at) with 1.25 micro diamondback 360 peripheral orbital atherectomy device (oad) the viperwire advance peripheral guide wire, extended length was scanned by the nurse and it showed the viperwire expired on (b)(6) 2025 two days prior to the procedure.The viperwire expired on the account¿s shelf.The physician was informed but decided to use the expired viperwire during atherectomy treatment.The patient was stable.There were no adverse patient effects.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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 received, the investigation determined that the reported improper or incorrect procedure or method - use after expiration appears to be related to user error.Per complaint details, the guide wire was intentionally used after its use-by date.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: codes 4118, 3233, and 11 no longer apply.
Event or Problem Description
It was reported that during procedure to treat moderately calcified, non-tortuous, 99% stenosed anterior tibial artery (at) with 1.25 micro diamondback 360 peripheral orbital atherectomy device (oad) the viperwire advance peripheral guide wire, extended length was scanned by the nurse and it showed the viperwire expired on 31august2025 two days prior to the procedure.The viperwire expired on the account¿s shelf.The physician was informed but decided to use the expired viperwire during atherectomy treatment.The patient was stable.There were no adverse patient effects.

• Brand Name: EXTENDED LENGTH 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: 23125130
• Report Number: 3004742232-2025-00284
• Device Sequence Number: 7741648
• Product Code: MCW
• UDI-Device Identifier: 10852528005459
• UDI-Public: (01)10852528005459(17)250831(10)505819-1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/31/2025

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 Expiration Date: 08/31/2025
• Device Model Number: VPR-GW-EL14
• Device Catalogue Number: 7-10035-01
• Device Lot Number: 505819-1
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White