BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14756963 · Received June 21, 2022

    Report

    Report Number
    3008452825-2022-00497
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    June 1, 2022
    Report Date
    July 14, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    UDI-DI
    05415067027665
    PMA / PMN Number
    P130026
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FSCA NUMBER: 3005334138-06/09/2022-003-R.

    Additional Manufacturer Narrative · 0

    FSCA NUMBER: (B)(6). THE REPORTED EVENT OF AN EXPIRED CATHETER WAS CONFIRMED. THE DEVICE WAS PROGRAMMED INCORRECTLY DURING MANUFACTURING, CONSISTENT WITH THE CATHETER BEING RECOGNIZED AS AN EXPIRED/INVALID PRODUCT AND WITH THE REPORTED EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. A CAPA EXISTS RELATED TO THIS COMPLAINT INVESTIGATION.

    Additional Manufacturer Narrative · 0

    FSCA NUMBER: 3005334138-06/09/2022-003-R. ADDITIONAL INFORMATION A3. PATIENT IS A MALE, BORN IN 1953.

    Description of Event or Problem · 0

    DURING THE ATRIAL FIBRILLATION, ATRIAL FLUTTER PROCEDURE, AN ERROR MESSAGE WAS DISPLAYED STATING THAT THE CATHETER PLUGGED INTO THE PRECISION LINK WAS EXPIRED. THE SYSTEM WAS UNABLE TO COLLECT THE MAGNETIC DATA, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612833 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 8409675 05415067027665

    Patients

    Seq Age Sex Outcome Treatment
    1 Male