BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM

    MDR report key: 20061062 · Received August 25, 2024

    Report

    Report Number
    2124215-2024-52980
    Event Type
    Malfunction
    Date Received
    August 25, 2024
    Date of Event
    August 21, 2024
    Report Date
    August 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FARAWAVE PULSED FIELD ABLATION CATHETER WAS PREPPED ACCORDING TO THE INSTRUCTION FOR USE. PRIOR TO INSERTING THE SHEATH, IT WAS VISUALLY CONFIRMED THAT THERE WAS AN ACTIVE DRIP COMING FROM THE PROXIMAL CATHETER TIP. AFTER COMPLETING THE PULMONARY VEIN ISOLATION, AND APPLICATION WAS ABOUT TO BEGIN TO TREAT THE CAVOTRICUSPID ISTHMUS (CTI), THE PHYSICIAN NOTICED THAT THE TABLE WAS SOAKING WET. THE CATHETER WAS IRRIGATED, AND NO ISSUE WAS NOTED WITH THE IRRIGATION SYSTEM. FURTHER INSPECTION REVEALED THAT THE FLUID BAG USED WITH THE CATHETER HAD BEEN COMPLETELY EMPTIED. ADDITIONALLY, THE CATHETER HANDLE HAD BEEN LEAKING EARLIER. IMMEDIATELY, THE CATHETER WAS WITHDRAWN FROM THE BODY, AND THE CTI ABLATION WAS COMPLETED USING A NON-BOSTON SCIENTIFIC RF ABLATION CATHETER AND NON-BOSTON SCIENTIFIC RF GENERATOR. THERE WERE NO PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481528 FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 0033936943 00191506043148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown