BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 23644613 · Received November 25, 2025

    Report

    Report Number
    3008452825-2025-00618
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    October 31, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    OAE
    UDI-DI
    05415067034571
    PMA / PMN Number
    P220013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC TAMPONADE AND PERICARDIAL EFFUSION ARE KNOWN RISKS DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    DURING PVC RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) MAPPING, A CARDIAC TAMPONADE OCCURRED WHICH REQUIRED CARDIAC SURGERY. THE PHYSICIAN WAS MAPPING IN THE AREA OF THE RVOT AND PERFORMED ONE RF APPLICATION. WHILE MAPPING, THE PATIENT MOVED AND STARTED COUGHING. THE PATIENT STARTED SWEATING AND A DROP IN BLOOD PRESSURE WAS OBSERVED. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED A TAMPONADE. TWO PERICARDIOCENTESIS PROCEDURES WERE PERFORMED AND THEN THE PATIENT UNDERWENT CARDIAC SURGERY TO REPAIR THE PERFORATION. THE PATIENT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2715637 TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿ Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation OAE ABBOTT MEDICAL A-TFSE-DF 10815635 05415067034571

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Life Threatening| R