BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE

    MDR report key: 22861325 · Received August 21, 2025

    Report

    Report Number
    2124215-2025-58419
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    October 1, 2021
    Report Date
    August 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE EVENT WAS RECEIVED AS A LITERATURE ABSTRACT, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # FOR THIS PRODUCT. ALL AVAILABLE PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT. NO DEVICE IS AVAILABLE FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    (B)(4). PER LITERATURE ABSTRACT, IT WAS REPORTED THAT 381 PATIENTS WITH LONGSTANDING PERSISTENT ATRIAL FIBRILLATION UNDERWENT LEFT ATRIAL ABLATION CONSISTING OF PULMONARY VEIN ISOLATION, LEFT ATRIAL POSTERIOR WALL BOX LESION, AND ABLATION AT THE MITRAL ISTHMUS BETWEEN OCTOBER 2021 TO NOVEMBER 2024, REPEAT ABLATION WAS PERFORMED IN 40 PATIENTS, OF WHOM 26 PATIENTS DISPLAYED 45 DISTINCT ATRIAL TACHYCARDIAC (AT) TYPES. MACROREENTRY ATS INCLUDED TYPICAL ATRIAL FLUTTER AND PERI-MITRAL REENTRY TACHYCARDIA (PMRT), WHILE NO ROOF-DEPENDENT REENTRY TACHYCARDIA WAS PRESENT. LOCALIZED (REENTRY OR ECTOPIC) AT SOURCES WERE FOUND OUTSIDE THE PRIOR PFA LESIONS. PMRT OCCURRED IN 9 PATIENTS WITHIN MI BLOCK, AND IN 12 PATIENTS DUE TO MI BLOCK RECOVERY. FIALA, M., LEHAR, F., CERNOSEK, M., JEZ, J., BULKOVA, V., FUNASAKO, M., RYBKA, L., TOMAN, O., & KALA, P. (2025). MITRAL ISTHMUS BLOCK AND RECURRENT PERI-MITRAL REENTRY TACHYCARDIA IN PATIENTS UNDERGOING PULSED FIELD ABLATION FOR LONGSTANDING PERSISTENT ATRIAL FIBRILLATION [ABSTRACT].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418669 FARAWAVE CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown