BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER

    MDR report key: 23181778 · Received September 30, 2025

    Report

    Report Number
    MW5176796
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    September 5, 2025
    Report Date
    September 25, 2025
    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, BIOSENSE WEBSTER, INC. NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-BIOSENSE WEBSTER, INC. PRODUCT. EVENT DESCRIPTION: DURING AN ATRIAL FIBRILLATION CASE, A PERICARDIAL EFFUSION WAS NOTICED. AFTER COMPLETING ABLATION IN THE RIGHT VEINS WITH THE FARAWAVE CATHETER AND THE FARADRIVE SHEATH, THE PATIENT HAD A DROP IN BLOOD PRESSURE. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS BEING SENT TO THE INTENSIVE CARE UNIT (ICU). NO BWI (BIOSENSE WEBSTER, INC.) CATHETERS WERE USED FOR MAPPING DURING THIS PROCEDURE. A REPROCESSED SOUNDSTAR CATHETER WAS USED FOR CARTOSOUND ONLY. THE SOUNDSTAR CATHETER WAS REPROCESSED BY STERILMED (BIO10438577/(B)(6). THE CALLER STATED THE PHYSICIAN BELIEVES A PERFORATION MAY HAVE OCCURRED ON THE LEFT SIDE OF THE HEART WHEN MANIPULATING THE FARAWAVE CATHETER. BOSTON SCIENTIFIC PFA (PULSED FIELD ABLATION) SYSTEM WAS IN USE. 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
    1796277 FARAWAVE PULSED FIELD ABLATION CATHETER PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WIT QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown