BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE NAV

    MDR report key: 23469500 · Received November 4, 2025

    Report

    Report Number
    2124215-2025-79323
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 7, 2025
    Report Date
    November 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PULMONARY VEIN ISOLATION AND PFA OF THE LEFT ATRIAL POSTERIOR WALL WAS PERFORMED USING FARAWAVE NAV CATHETER. A 31 MM FARAWAVE NAV CATHETER WAS LOADED ONTO A MERIT INQWIRE 0.035 ROSEN J TIP GUIDEWIRE AND THE FARAWAVE NAV CATHETER WAS ADVANCED INTO POSITION IN THE LEFT ATRIUM. THE FARAWAVE NAV CATHETER WAS DEPLOYED INTO FLOWER CONFIGURATION AND A SPLINE PLANARITY ISSUE OCCURRED. THE FARAWAVE NAV CATHETER WAS REMOVED FROM THE PATIENT AND FUNCTIONAL TESTING WAS PERFORMED. THE MERIT INQWIRE 0.035 ROSEN J TIP GUIDEWIRE WAS ADVANCED PAST THE TIP THE FARAWAVE NAV CATHETER AND WAS UNABLE TO BE REMOVED FROM THE CATHETER. THE FARAWAVE NAV CATHETER AND MERIT INQWIRE 0.035 ROSEN J TIP GUIDEWIRE WERE EXCHANGED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588069 FARAWAVE NAV CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 0037297767 00191506043193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown