BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAPULSE CATHETER

    MDR report key: 24114487 · Received January 20, 2026

    Report

    Report Number
    MW5182407
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    December 5, 2025
    Report Date
    January 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6) NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6), INC PRODUCT. SITUATION: VENTRICULAR FIBRILLATION (VF) OCCURRED. TIMING - IMMEDIATELY AFTER PULSED FIELD ABLATION (PFA) WAS PERFORMED NEAR THE BOTTOM OF THE RIGHT INFERIOR PULMONARY VEIN WITH FARAPULSE. HOW TO COMPLETE THE PROCEDURE - VF WAS STOPPED BY PERFORMING EXTERNAL DIRECT CURRENT (DC) CARDIOVERSION. THE PFA WAS THEN COMPLETED, A POST-MAP WAS CREATED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. DESCRIPTION OF ADVERSE EVENT: VENTRICULAR FIBRILLATION. PROGRESS: DURING THE PROCEDURE, EXTERNAL DC CARDIOVERSION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. PHYSICIAN'S JUDGMENT ON HEALTH HAZARD: NON-SERIOUS (MODERATE/MINOR). EXTENDED HOSPITALIZATION: NO. CAUSAL RELATIONSHIP WITH THE PRODUCT: UNKNOWN. WERE ANY ABNORMALITIES OBSERVED PRIOR TO USE OF THE PRODUCT? NONE. WERE ANY ABNORMALITIES OBSERVED DURING USE OF THE PRODUCT? NONE. THE COMPLAINT PRODUCT(S) WILL NOT BE RETURNED FOR ANALYSIS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177920 FARAPULSE CATHETER PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown