BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE

    MDR report key: 23594927 · Received November 19, 2025

    Report

    Report Number
    MW5179023
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 17, 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

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) CASE, A PERICARDIAL EFFUSION WAS NOTICED. THE PERICARDIAL EFFUSION WAS DISCOVERED DURING THE WATCHMAN¿ PORTION OF THE PROCEDURE USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE REPORTER CONFIRMED ALL PULSED FIELD ABLATION (PFA) APPLICATIONS HAD ALREADY BEEN COMPLETED WHEN THE INJURY WAS DISCOVERED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY TEE. NO MEDICAL INTERVENTION WAS PROVIDED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THEY WERE INFORMED AFTER THE PROCEDURE HAD ALREADY BEEN COMPLETED. THE PHYSICIAN DID NOT MENTION WHAT THEY THOUGHT CAUSED THE PERICARDIAL EFFUSION. THEY USED THE FARAPULSE¿ SYSTEM FOR PFA USING THE FARAWAVE¿ CATHETER. THE PENTARAY CATHETER WAS USED FOR MAPPING, BUT IT IS NOT AVAILABLE FOR RETURN, AND THE REPORTER COULD NOT PROVIDE THE LOT NUMBER. PT CODE: 3271. DEVICE CODE: 2993. PROCODE: QZI. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORT: MW5179024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313761 FARAWAVE PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown