BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 13001703 · Received December 14, 2021

    Report

    Report Number
    3008452825-2021-00557
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 25, 2021
    Report Date
    December 14, 2021
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    UDI-DI
    05415067027641
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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; HOWEVER, THE LOG FILES FROM THE TACTISYS QUARTZ SYSTEM WERE RETURNED. THE LOG FILE ANALYSIS CONCLUDED THAT THE TACTICATH CATHETER PERFORMED AS INTENDED. THE OPTICAL FIBERS MET SPECIFICATIONS, THE RECORDED TEMPERATURES INDICATED COOLING DURING RF ABLATION, AND CONTACT FORCE MEASUREMENTS WERE DISPLAYED THROUGHOUT THE DURATION OF THE LOG FILES. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 0

    DURING AN ATRIAL FIBRILLATION PROCEDURE, A CARDIAC TAMPONADE WAS OBSERVED. WHILE THE ABLATION CATHETER WAS IN THE LEFT ATRIUM (LA), AT THE ANTERIOR WALL LOOKING FOR THE CFE, THE CATHETER APPEARED SLIGHTLY OUTSIDE THE GEOMETRY WITH AN IMPEDANCE SLIGHTLY HIGHER THAN THE LA. THE CATHETER WAS MOVED, BUT NOT POSTERIOR. THE CATHETER WAS THEN MOVED A FEW CENTIMETERS AND THE CATHETER WAS BACK IN THE LA WITH GOOD IMPEDANCE. A FEW MINUTES LATER, THE PATIENT BECAME HYPOTENSIVE, AND A CARDIAC TAMPONADE WAS REVEALED VIA TRANSOESOPHAGEAL ECHO (ETO) AND TRANS THORACIC ECHO (ETT). THE BLOOD WAS DRAINED AND THE PATIENT WAS STABILIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898578 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 8001682 05415067027641

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention