BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM

    MDR report key: 20216191 · Received September 13, 2024

    Report

    Report Number
    2124215-2024-57419
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 26, 2024
    Report Date
    January 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE FARAWAVE CATHETER WAS ANALYZED. VISUAL INSPECTION FOUND THAT THE FLUSH LUER DETACHED FROM THE FLUSH PORT. FUNCTIONAL TESTING WAS PERFORMED, AND A GUIDEWIRE WAS INSERTED THROUGH THE CATHETER. THE CATHETER WAS DEPLOYED TO THE BASKET CONFIGURATION AND SUCCESSFULLY FLOWED. MICROSCOPIC INSPECTION WAS PERFORMED AND CONFIRMED THE SEPARATION OF THE STRAIN RELIEF/LUER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSERTION, THE FLUSH PORT ON THE FARAWAVE PULSED FIELD ABLATION CATHETER WAS OBSERVED TO BE DAMAGED AND HAD BROKEN OFF. SUBSEQUENTLY, THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO RETURN FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSERTION, THE FLUSH PORT ON THE FARAWAVE PULSED FIELD ABLATION CATHETER WAS OBSERVED TO BE DAMAGED AND HAD BROKEN OFF. SUBSEQUENTLY, THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS. THE CATHETER WAS RECEIVED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209167 FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 0034459633 00191506043148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown