BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM

    MDR report key: 19819715 · Received July 24, 2024

    Report

    Report Number
    2124215-2024-45675
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT AN ATRIAL FIBRILLATION A FARAWAVE PULSED FIELD ABLATION CATHETER WAS SELECTED FOR USE. THE CATHETER WAS PREPARED PROPERLY AND PRE-INSERTION IRRIGATION WAS CONFIRMED TO BE WORKING FINE. DURING INSERTION, IT WAS OBSERVED THAT THE FLOW WAS NOT THE USUAL AND THERE WAS NO FLOW WHEN DEPLOYED TO FLOWER. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349686 FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 0034032636 00191506043148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male