BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM

    MDR report key: 19949123 · Received August 9, 2024

    Report

    Report Number
    2124215-2024-49525
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 22, 2024
    Report Date
    October 7, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR.: UPON RECEIPT AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY, THE FARAWAVE CATHETER WAS VISUALLY INSPECTED. VISUAL INSPECTION OF THE DEVICE NOTED SOME BUBBLES OR OCCLUSION OBSERVED INSIDE THE FLUSH LUMEN. A GUIDEWIRE WAS INSERTED THROUGH THE CATHETER, AND THE CATHETER WAS DEPLOYED TO BASKET AND FLOWER WITHOUT DIFFICULTY. FLUSHING WAS THEN TESTED THROUGH THE IRRIGATION LINE. FLUSHING WAS FUNCTIONAL IN ALL DEPLOYMENT STATES. THE OBSERVED MATERIAL INSIDE THE FLUSH LUMEN WAS FOUND TO BE CONSISTENT WITH ADHESIVE. IT IS NOT ABNORMAL TO POTENTIALLY HAVE THE ADHESIVE FLOW IN BETWEEN THE FLUSH LUMEN AND STRAIN RELIEF, RESULTING IN THE OBSERVED BUBBLES. SINCE FLUSHING THROUGH THE LUMEN WAS FUNCTIONAL, NO LEAK PATH ALLOWED FOR THE ADHESIVE TO FLOW INTO THE FLUSH LUMEN AND CAUSE AN OCCLUSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR BUBBLES WERE VISUALIZED. DURING PREPARATION FOR A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT ATRIAL FIBRILLATION, A FARAWAVE PFA CATHETER WAS SELECTED FOR USE. THE CATHETER WAS PREPPED, AND THE SIDE PORT WAS CONNECTED TO THE FLUSH LINE. WHILE TESTING, THE CATHETER WAS FLUSHED, BUT IT WAS NOTED THAT THE SIDE PORT HAD BUBBLES. THE LUMEN WAS TAPPED IN AN ATTEMPT TO RESOLVE THE ISSUE, BUT THIS MITIGATION ATTEMPT WAS UNSUCCESSFUL. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY WHERE IT IS AWAITING ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR BUBBLES WERE VISUALIZED. DURING PREPARATION FOR A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT ATRIAL FIBRILLATION, A FARAWAVE PFA CATHETER WAS SELECTED FOR USE. THE CATHETER WAS PREPPED, AND THE SIDE PORT WAS CONNECTED TO THE FLUSH LINE. WHILE TESTING, THE CATHETER WAS FLUSHED, BUT IT WAS NOTED THAT THE SIDE PORT HAD BUBBLES. THE LUMEN WAS TAPPED IN AN ATTEMPT TO RESOLVE THE ISSUE, BUT THIS MITIGATION ATTEMPT WAS UNSUCCESSFUL. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY WHERE IT IS AWAITING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514534 FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 0034268825 00191506043148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female