BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 23142513 · Received September 25, 2025

    Report

    Report Number
    23142513
    Event Type
    Death
    Date Received
    September 25, 2025
    Date of Event
    July 3, 2025
    Report Date
    July 15, 2025
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    OAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PROCEDURE TO BE PERFORMED ON PATIENT IS PULSED FIELD ABLATION (PFA) ATRIAL FIBRILLATION ABLATION. AFTER TRANSEPTAL ACCESS ACHIEVED, HAD TECHNICAL DIFFICULTIES RESULTING IN SYSTEM REBOOT. DURING THIS DOWNTIME, PATIENT BECAME HEMODYNAMICALLY UNSTABLE REQUIRING CPR, PERICARDIOCENTESIS, RAPID BLOOD TRANSFUSION. CPR IN PROGRESS FROM 1245-1410. TOD: 1410.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493501 BIOSENSE WEBSTER THERMOCOOL SMARTTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER OAE BIOSENSE WEBSTER 31568879L

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death