BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE NAV

    MDR report key: 23597478 · Received November 19, 2025

    Report

    Report Number
    2124215-2025-84109
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A STUCK GUIDEWIRE OCCURRED. A PULSE FIELD ABLATION (PFA) PROCEDURE FOR ATRIAL FIBRILLATION WAS PERFORMED USING FARAWAVE NAV CATHETER. A 31MM FARAWAVE NAV CATHETER WAS LOADED ONTO A NON-BOSTON SCIENTIFIC GUIDEWIRE AND THE FARAWAVE NAV CATHETER WAS ADVANCED INTO POSITION IN THE LEFT ATRIUM. WHILE ATTEMPTING TO CANNULATE THE RIGHT PULMONARY VEINS, THE GUIDEWIRE WAS UNABLE TO BE ADVANCED OR RETRACTED WITHIN THE FARAWAVE NAV CATHETER. THE FARAWAVE NAV CATHETER WAS REMOVED FROM THE PATIENT, NO TISSUE ENTRAPMENT WAS APPARENT, AND THE GUIDEWIRE WAS UNABLE TO BE REMOVED FROM THE FARAWAVE NAV. A NEW FARAWAVE NAV CATHETER WAS SELECTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341230 FARAWAVE NAV CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 0037284458 00191506043193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown