BEUDAMED
    FDA Adverse Event Death Summary report: N

    FARAWAVE PULSED FIELD ABLATION (PFA) SYSTEM / FARAPULSE GEN

    MDR report key: 22493594 · Received July 14, 2025

    Report

    Report Number
    MW5172543
    Event Type
    Death
    Date Received
    July 14, 2025
    Date of Event
    July 3, 2025
    Report Date
    July 9, 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 THAT THE CARTO 3 SYSTEM WAS DISPLAYING ERROR 1006, BACK PATCH SENSOR ERROR, INTERMITTENTLY AT FIRST, THEN CONSTANT. THE CALLER WAS ADVISED TO REPLACE THE BACK PATCH SENSOR CABLES AND TO REBOOT THE CARTO 3 SYSTEM. THE PIU WAS TURNED OFF WHEN THE ANESTHESIOLOGIST ADVISED THAT THE PATIENT WAS HYPOTENSIVE. THE PHYSICIAN OPTED TO FORGO TROUBLESHOOTING AT THIS TIME. CAS WILL CALL BACK. CAS CALLED BACK STATING THAT AFTER THE FIRST CALL, A STAT ECHO WAS ORDERED. THE PATIENT WAS IN TAMPONADE AND CPR WAS STARTED (12:45 CENTRAL TIME). A PERICARDIOCENTESIS WAS PERFORMED. UNKNOWN AMOUNT OF FLUID REMOVED. BLOOD AND PLASMA PRODUCTS WERE GIVEN ALONG WITH ACLS CODE PROTOCOL. CARDIOTHORACIC SURGERY WAS CALLED. THE PATIENT EXPIRED (14:10 CST) BEFORE SURGERY WAS AVAILABLE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA OF A FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729612 FARAWAVE PULSED FIELD ABLATION (PFA) SYSTEM / FARAPULSE GEN PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death CARTO 3 SYSTEM 8.1.1.944, SN (B)(6).| FARAWAVE PFA CATHETER.| STERILMED SOUNDSTAR OCTARAY CATHETER