BEUDAMED
    FDA Adverse Event Death Summary report: N

    FARAWAVE NAV

    MDR report key: 23346089 · Received October 21, 2025

    Report

    Report Number
    2124215-2025-74870
    Event Type
    Death
    Date Received
    October 21, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS NOT AVAILABLE BECAUSE THE DEVICE WAS DISCARDED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA, CARDIAC DECOMPENSATION, LIVER AND KIDNEY FAILURE, THEN SUBSEQUENTLY DIED. AFTER A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT ATRIAL FIBRILLATION USING A FARAWAVE CATHETER THE PATIENT BECAME BRADYCARDIC AND DECOMPENSATED IN THE POST ANESTHESIA CARE UNIT (PACU). THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE DUE TO THE COMPLICATIONS. THE PATIENT'S CONDITION CONTINUED TO WORSEN WITH LIVER AND KIDNEY FAILURE, AND THE PATIENT DIED TWO OR THREE DAYS AFTER THE PROCEDURE. THE OFFICIAL CAUSE OF DEATH WAS LISTED AS LIVER AND KIDNEY FAILURE (END ORGAN FAILURE). IT IS UNKNOWN IF ANY MEDICAL INTERVENTION WAS ATTEMPTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS DUE TO DISPOSAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284570 FARAWAVE NAV CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 00191506043193

    Patients

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