BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE PULSED FIE LD ABLATION CATHETER, 31MM

    MDR report key: 21148309 · Received January 14, 2025

    Report

    Report Number
    2124215-2025-00633
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    December 17, 2024
    Report Date
    January 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043148
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARAWAVE PFA CATHETER ONE OF THE PATIENT'S CHORDAE TENDINEAE WERE TORN IN THE RIGHT ATRIUM. ABLATIONS WERE PERFORMED ON THE CTI LINE, THESE ABLATIONS ARE CONSIDERED OFF LABEL USE AS THE FARAWAVE IS ONLY INDICATED FOR PULMONARY VEIN ISOLATIONS. WHEN REPOSITIONING THE CATHETER THE ARRAY OF THE CATHETER FELL INTO THE RIGHT VENTRICLE AND WAS DIFFICULT TO REMOVE. THEY MANIPULATED THE CATHETER CAREFULLY AND CHANGED THE DEPLOYMENT STATE IN ORDER TO FINALLY FREE THE CATHETER. THEY CHECKED THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) BEING USED FOR THE PROCEDURE AND SAW THAT A CHORDAE WAS TORN. THE PATIENT WAS NOT HOSPITALIZED AND NO MEDICAL OR SURGICAL INTERVENTIONS TOOK PLACE. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL CATHETER WITH NO FURTHER COMPLICATIONS. THE CATHETER WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED AS THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987626 FARAWAVE PULSED FIE LD ABLATION CATHETER, 31MM CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 0035141653 00191506043148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other