BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18344516 · Received December 18, 2023

    Report

    Report Number
    3008452825-2023-00576
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    November 27, 2023
    Report Date
    December 20, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    UDI-DI
    05415067027641
    PMA / PMN Number
    P130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 CONTACT FORCE ISSUE AND SUBSEQUENT DELAY REMAIN UNKNOWN.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REF: 3008452825-2023-00575. DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THE CONTACT FORCE MEASUREMENT WAS NOT ACCURATE WHICH CAUSED A DELAY IN PROCEDURE. WHEN USING ENSITE PRECISION, THE CONTACT FORCE MEASUREMENT WAS NOT ACCURATE AS THE MEASURED FORCE AT RANDOM WAS ZERO AND 440 G, AND THEN TO 12 G, WITHOUT MOVEMENT OF THE CATHETER. CONNECTIONS WERE CHECKED AND THE TACTISYS MODULE WAS REPLACED, WHICH DID NOT RESOLVE THE ISSUE. THE CATHETER WAS THEN EXCHANGED, AND THE ISSUE WAS RESOLVED; HOWEVER, THE ISSUE OCCURRED AGAIN, WITH RANDOM FORCE READINGS AT 0 G TO 18 G TO 5 G (APPROPRIATE UNTIL CONTACT FORCE LOSS) AND 410 G WAS DISPLAYED INTERMITTENTLY. THE PROCEDURE WAS COMPLETED USING INTRACARDIAC ECHO, WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59306 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL A-TCSE-DF 9213783 05415067027641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE