BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13969272 · Received March 31, 2022

    Report

    Report Number
    3008452825-2022-00199
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    February 24, 2022
    Report Date
    April 21, 2022
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    OAE
    UDI-DI
    05415067027641
    PMA / PMN Number
    P130026
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FSCA NUMBER: 3005334138-3/22/22-001-R. PRODUCT #1 PI MAIN [PI-2022-0031152-01]. THE REPORTED EVENT OF A CATHETER NOT BEING DISPLAYED WAS CONFIRMED. THE RETURNED DEVICE WAS INADVERTENTLY PROGRAMMED DURING MANUFACTURING, CONSISTENT WITH A LOSS IN CONTACT FORCE FUNCTIONALITY AND WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS INADVERTENTLY PROGRAMMED DURING MANUFACTURING, CONSISTENT WITH A LOSS IN CONTACT FORCE FUNCTIONALITY AND WITH THE REPORTED EVENT.

    Description of Event or Problem · 0

    DURING DEVICE PREPARATION, IT WAS NOTED THE CATHETER WAS NOT DISPLAYED. THE CONNECTIONS WERE CHECKED WITH NO RESOLUTION. THE CATHETER AND TACTISYS PORTS WERE BLOWN OUT WITH CAN AIR WITH NO RESOLUTION. THE TACTISYS WAS EXCHANGED WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2190392 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL, COSTA RICA LTDA A-TCSE-DF 8197913 05415067027641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown