BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE¿ PULSED FIELD ABLATION (PFA) CATHETER

    MDR report key: 21265829 · Received January 29, 2025

    Report

    Report Number
    MW5165420
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    November 11, 2024
    Report Date
    January 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER AN ATRIAL FIBRILLATION (AFIB) CASE, A DIFFUSE ALVEOLAR HEMORRHAGE (DAH) WAS NOTICED. THE REPORTER STATED THAT WHEN THE PATIENT WOKE UP, THE PATIENT WAS SHORT OF BREATH AND COUGHING UP BLOOD. THE DAH WAS CONFIRMED BY A CHEST X-RAY. THE MEDICAL INTERVENTION PROVIDED WAS UNKNOWN. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IN THE PHYSICIAN¿S OPINION, THE ADVERSE EVENT WAS NOT CAUSED BY THE J&J PRODUCTS USED IN THE CASE. THE PHYSICIAN BELIEVED THAT IT WAS EITHER PULSED FIELD ABLATION (PFA) ENERGY DELIVERY RELATED, OR THAT THE GUIDEWIRE IN THE FARAWAVE¿ WENT TOO FAR OUT THE PULMONARY VEIN AND PUNCTURED THE ALVEOLI. THE PATIENT FULLY RECOVERED. 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
    578542 FARAWAVE¿ PULSED FIELD ABLATION (PFA) CATHETER PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown