BEUDAMED
    FDA Adverse Event Death Summary report: N

    FARAWAVE NAV

    MDR report key: 23610099 · Received November 20, 2025

    Report

    Report Number
    2124215-2025-85204
    Event Type
    Death
    Date Received
    November 20, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: COMMON DEVICE NAME: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH IRREVERSIBLE ELECTROPORATION; REPORTED HERE AS THE COMMON DEVICE NAME EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION AND VENTRICULAR FLUTTER, A FARAWAVE NAV CATHETER WAS SELECTED FOR USE. POSTERIOR WALL AND VEIN ISOLATION WERE PERFORMED USING THE FARAWAVE NAV CATHETER. THIS WAS FOLLOWED BY AN ANTERIOR MITRAL LINE ATTEMPT TO TREAT FLUTTER. USE OF THE CATHETER TO TREAT ANTERIOR MITRAL LINE CONSTITUTED OFF-LABEL USE OF THE CATHETER. AT THIS POINT, THE BLOOD PRESSURE OF THE PATIENT DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE ABLATION HAD BEEN TAKING PLACE FOR 30 MINUTES WHEN THIS EVENT WAS NOTICED. A PERICARDIAL TAP AND DRAIN WERE PERFORMED IN RESPONSE TO THE PATIENT COMPLICATION. THE PATIENT WAS HOSPITALIZED IN RESPONSE TO THE EVENT. ONE DAY POST PROCEDURE, THE PATIENT DIED. THE CAUSE OF DEATH WAS RULED AS A CARDIAC EXHAUSTION. THE FARAWAVE CATHETER IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS SINCE IT WAS DISPOSED. ADDITIONALLY, THE CATHETER EXHIBITED A SPLINE INVERSION, BUT THIS WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2475747 FARAWAVE NAV No Match QZI BOSTON SCIENTIFIC CORPORATION 0037184010 00191506043193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| H| R