BEUDAMED
    FDA Adverse Event Death Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE F-J

    MDR report key: 20600165 · Received November 4, 2024

    Report

    Report Number
    3008452825-2024-00644
    Event Type
    Death
    Date Received
    November 4, 2024
    Date of Event
    October 28, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    UDI-DI
    05415067027665
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED ACUTE CORONARY SYNDROME, EVOLVING WITH SUSTAINED VENTRICULAR TACHYCARDIA, VENTRICULAR FIBRILLATION, CARDIOGENIC SHOCK, CARDIORESPIRATORY ARREST, AND SUBSEQUENT PATIENT DEATH REMAINS UNKNOWN.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME DURING THE ELECTROPHYSIOLOGICAL STUDY AND ABLATION PROCEDURE, EVOLVING WITH SUSTAINED VENTRICULAR TACHYCARDIA, VENTRICULAR FIBRILLATION, CARDIOGENIC SHOCK, CARDIORESPIRATORY ARREST AND EXPIRED.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME DURING THE ELECTROPHYSIOLOGICAL STUDY AND ABLATION PROCEDURE, EVOLVING WITH SUSTAINED VENTRICULAR TACHYCARDIA, VENTRICULAR FIBRILLATION, CARDIOGENIC SHOCK, CARDIORESPIRATORY ARREST AND EXPIRED. NO ABLATION WAS PERFORMED PRIOR TO THE OCCURRENCE OF ACUTE CORONARY SYNDROME. THERE WERE NO ALLEGED DEVICE DEFICIENCIES OR PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2189047 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE F-J CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL A-TCSE-FJ 10241409 05415067027665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death