BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTIFLEX SE F-CURVE ABLATION CATHETER

    MDR report key: 24198807 · Received January 28, 2026

    Report

    Report Number
    3008452825-2026-00039
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 28, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    OAE
    UDI-DI
    05415067034670
    PMA / PMN Number
    P220013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. 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. THE PRODUCT'S LOT NUMBER COULD NOT BE OBTAINED, THEREFORE THE PRIMARY DI NUMBER IS PROVIDED (D4), BUT FULL UDI INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 0

    DURING AN ATRIAL FLUTTER PROCEDURE, WHILE ABLATING THE CAVO-TRICUSPID ISTHMUS (CTI), A PRESSURE INDUCED PERFORATION OCCURRED WHICH REQUIRED SURGERY. THE PERFORATION WAS SUCCESSFULLY REPAIRED AND THE PATIENT STABILIZED. A BASAL POSTERIOR PERFORATION IN THE RIGHT VENTRICLE WAS CONFIRMED DURING SURGERY. THE PATIENT HAD A HYPER-MOBILE AND TORTUOUS CTI. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259778 TACTIFLEX SE F-CURVE ABLATION CATHETER Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation OAE ABBOTT MEDICAL A-TFSE-F 05415067034670

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Life Threatening| R