BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE,ST,MOD,S,HY,US 95-014

    MDR report key: 24323668 · Received February 12, 2026

    Report

    Report Number
    3006010712-2026-00004
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 12, 2026
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K160643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION COMPLETED AS PART OF THIS REPORT.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: ECN EVENT DESCRIPTION: STOP SHORT TECHNIQUE AFTER TRYING TO ENGAGE ECA, THE .035 JUMPED AND THE PHYSICIAN FEELS LIKE IT CAUSED THE INJURY TO THE VESSEL. ONCE THE NPS WAS SET UP, THE MD TRIED TO WIRE THE ICA, SWAPPED THE ENROUTE WIRE OUT FOR A V-14, THE WIRE SEEMED TO ENGAGE THE ICA, WE BALLOONED AND STENTED. WHEN THE FINAL ANGIOGRAM WAS TAKEN IT WAS CLEAR THE STENT WAS PLACED OUTSIDE THE ICA. WE ORIGINALLY THOUGHT IT WAS PLACED IN THE ECA, BUT UPON EXPLANT IT ACTUALLY PERFORATED THE ICA. THE MD DID A CEA, PLACED A PATCH, AND THE PATIENT IS RECOVERING WELL. BASED ON THE EVENT DESCRIPTION: - THE J-WIRE JUMPED AND CAUSED A DISSECTION DURING THE PROCEDURE; THEREFORE WE NEED A COMPLAINT FOR THE NPS SYSTEM. - THE DISSECTION COULD ALSO HAVE OCCURRED WITH THE V-14 WIRE AS WELL AND THEREFORE WE NEED A V-14 COMPLAINT ALSO. EVENT DATE: 2026-1-27 AS REPORTED DEVICE CODES: 2442: UNINTENDED MOVEMENT AS REPORTED PATIENT CODES: 9213: PERFORATION PROCEDURE DATE: (B)(6) 2026. TYPE OF PROCEDURE: TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) COUNTRY OF EVENT: UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362521 ENROUTE,ST,MOD,S,HY,US 95-014 ENROUTE 014 GUIDEWIRE DQX LAKE REGION MEDICAL 901047-01 UNKNWON

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown