BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM

    MDR report key: 21229985 · Received January 24, 2025

    Report

    Report Number
    2124215-2025-03383
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    January 8, 2025
    Report Date
    January 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THE PATIENT EXPERIENCED SPASM. AFTER PERFORMING ABLATION ON THE PULMONARY VEIN AND POSTERIOR WALL WITH A FARAWAVE PULSED FIELD ABLATION CATHETER, A CORONARY ANGIOGRAPHY (CAG) WAS CONDUCTED. THEN 22 FLOWER ABLATIONS WERE PERFORMED IN THE MITRAL ISTHMUS. POST-ABLATION, A SUBSEQUENT CAG INDICATED A SLIGHT PROGRESSION OF SPASM COMPARED TO THE PRE-ABLATION STATE, PROMPTING THE ADMINISTRATION OF A NITROGLYCERIN CORONARY INJECTION. A FOLLOW-UP CAG A FEW MINUTES LATER CONFIRMED RECOVERY. ADDITIONALLY, THE DEVICE WAS USED OFF-LABEL AFTER PULMONARY VEIN ISOLATION DUE TO AN ATRIAL FIBRILLATION AND MITRAL ATRIAL FLUTTER OCCURRING. THE DEVICE IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717289 FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 0035402545 00191506043148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention