BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER

    MDR report key: 20230730 · Received September 16, 2024

    Report

    Report Number
    2124215-2024-57698
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    July 5, 2024
    Report Date
    September 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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 A FARAWAVE 31 MM DURING PROCEDURE TO TREAT AN ATRIAL FIBRILLATION (A FIB) PRESENTED THE GUIDEWIRE STUCK. PERFORMED PVI AND PWI ISOLATION WITH FARAWAVE 31MM CATHETER. REMOVED TO DO POST MAPPING. WENT TO REINSERT FARAWAVE TO PERFORM CTI ABLATION ON RIGHT SIDE AND ROSEN WIRE WOULD NOT PASS THROUGH THE HANDLE OF THE CATHETER. (THESE ANATOMY LOCATIONS PWI AND CTI ARE CONSIDERED OFF LABEL). DOCTOR ASKED FOR 2ND FARAWAVE CATHETER, THEN THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS RETAINED BY THE COSTUMER, AND IT'S NOT EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901272 FARAWAVE PULSED FIELD ABLATION CATHETER CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 00191506043148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown