BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM

    MDR report key: 20857988 · Received December 5, 2024

    Report

    Report Number
    2124215-2024-76968
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    November 15, 2024
    Report Date
    December 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 FOREIGN MATERIAL WAS PRESENT IN THE DEVICE. DURING PREPARATION FOR A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION AND POSTERIOR WALL ISOLATION (PWI), A FARAWAVE CATHETER WAS SELECTED FOR USE. USE OF THE DEVICE TO PERFORM PWI CONSTITUTED OFF-LABEL USE, AS THE CATHETER IS ONLY INDICATED TO PERFORM PULMONARY VEIN ISOLATION PER THE INSTRUCTIONS FOR USE (IFU). DURING PREPARATION, A VERY DISTINCT HAZE IN THE FLUSH PORT THAT WOULD NOT GO AWAY WAS NOTICED EVEN DURING FLUSHING. THIS CATHETER WAS DEEMED TO BE CONTAMINATED BY THE FACILITY, AND A SECOND CATHETER WAS TAKEN. THE SECOND FARAWAVE CATHETER EXPERIENCED DIFFICULTY FLUSHING. A THIRD CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE CATHETER IS NOT EXPECTED TO RETURN FOR ANALYSIS AS IT WAS RETAINED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289783 FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 0034977913 00191506043148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown