BEUDAMED
    FDA Adverse Event Death Summary report: N

    FARAWAVE NAV

    MDR report key: 23238796 · Received October 7, 2025

    Report

    Report Number
    2124215-2025-71072
    Event Type
    Death
    Date Received
    October 7, 2025
    Date of Event
    September 25, 2025
    Report Date
    October 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC DUE TO THE TIMING OF THE ADVERSE EVENT POST PROCEDURE. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. 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

    THE PATIENT PRESENTED WITH PERSISTENT ATRIAL FIBRILLATION AND THE PHYSICIAN DECIDED TO TREAT THE PATIENTS' PULMONARY VEINS AND POSTERIOR WALL WITH PULSED FIELD ABLATION WITH A FARAWAVE NAV CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS AND TO OUR KNOWLEDGE LEFT THE LAB IN SINUS RHYTHM. IT WAS REPORTED THAT THE PATIENT HAD DIED A DAY AFTER THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS NOT EXPECTED TO RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440632 FARAWAVE NAV CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Death