BEUDAMED
    FDA Adverse Event Death Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER

    MDR report key: 20166879 · Received September 9, 2024

    Report

    Report Number
    2124215-2024-55395
    Event Type
    Death
    Date Received
    September 9, 2024
    Date of Event
    June 28, 2024
    Report Date
    April 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. THIS INCIDENT WAS REPORTED ANONYMOUSLY, THUS GOOD FAITH EFFORTS TO OBTAIN THIS INFORMATION WAS NOT POSSIBLE. 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 A PATIENT DEATH OCCURRED AFTER A PULSED FIELD ABLATION (PFA) PROCEDURE WITH A FARAWAVE PULSED FIELD ABLATION CATHETER. DURING THE PROCEDURE, THE GUIDEWIRE INSIDE THE FARAWAVE CATHETER WAS ADVANCED TOO FAR OUT INTO THE VEIN AND THE PATIENT BEGAN BLEEDING OUT OF THE TUBE CONNECTED TO THE VENTILATOR. THE PATIENT VITAL SIGNS WERE STABLE; HENCE THE PROCEDURE WAS CONTINUED. A BRONCHOSCOPY WAS PERFORMED, BUT NO DAMAGE WAS OBSERVED AT THE TIME. THE PROCEDURE WAS COMPLETED AND AFTER ALL DEVICES WERE REMOVED, IT WAS NOTICED THAT THE PATIENT BLOOD PRESSURE WAS 30/20. THE PATIENT WAS CODING AND COMPRESSIONS WERE PERFORMED, THEN, THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND WAS TAKEN TO A COMPUTED TOMOGRAPHY (CT) SCAN. THE PATIENT WAS PLACED ON ECMO AND THEN COMFORT CARE, LEADING TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563406 FARAWAVE PULSED FIELD ABLATION CATHETER CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death