BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 23596856 · Received November 19, 2025

    Report

    Report Number
    3008452825-2025-00592
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    November 10, 2025
    Report Date
    February 24, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    OAE
    UDI-DI
    05415067034571
    PMA / PMN Number
    P220013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6, H11. ONE BI-DIRECTIONAL, CURVE D-F, TACTIFLEX ABLATION CATHETER, SENSOR ENABLED WAS RECEIVED FOR EVALUATION. THE DEVICE WAS RETURNED DUE TO THE REPORTED EVENT OF A MAGNETIC SENSOR ISSUE, DISPLAY ISSUE, AND CONTACT FORCE VECTOR DISPLAY ISSUE. ONE OF THE MAGNETIC SENSORS READ AS AN OPEN CIRCUIT DURING ELECTRICAL TESTING, CONSISTENT WITH THE REPORTED EVENT. FURTHER INVESTIGATION REVEALED THE BACKFILL ADHESIVE HAD BEEN FRACTURED JUST PROXIMAL TO THE SENSOR COILS. SENSOR WIRES 3 AND 4 WERE DETERMINED TO BE FRACTURED AT THE LOCATION OF THE BACKFILL ADHESIVE FRACTURE, CONSISTENT WITH THE DETECTED OPEN CIRCUIT, AND THE REPORTED EVENT. IN ADDITION, ELECTRODES 1-4 AND BOTH THERMOCOUPLES MET SPECIFICATIONS DURING ELECTRICAL TESTING WITH NO OPEN OR SHORT CIRCUITS DETECTED. OPTICAL FIBERS 1-3 MET SPECIFICATIONS FOR OPTICAL PROPERTIES, THE TEMPERATURE READING OF BOTH THERMOCOUPLES INCREASED WITH EXPOSURE TO HEAT, AND NO LEAKS WERE DETECTED DURING LEAK TESTING. NO ANOMALIES WERE NOTED ON THE 10 PIN EEPROM PAYLOAD. THE BATCH RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE BACKFILL ADHESIVE FRACTURE AND SUBSEQUENT FRACTURED SENSOR WIRES REMAINS UNKNOWN.

    Description of Event or Problem · 0

    DURING THE PREMATURE VENTRICULAR COMPLEXES PROCEDURE, THERE WAS A DELAY DUE TO MAGNETIC SENSOR AND DISPLAY ISSUES. THE CATHETER WAS INSERTED INTO THE RIGHT VENTRICLE AND DURING MAPPING, THE CATHETER WOULD FLICKER INTERMITTENTLY WITH THE RED ICON SHOWING A MAGNETIC SENSOR ERROR. THE MODE WAS CHANGED FROM VOXEL TO NAVX AS THE CONTACT FORCE VECTOR DID NOT DISPLAY. ABLATION WAS PERFORMED IN THE RIGHT VENTRICLE SUCCESSFULLY. IT WAS THEN REQUIRED TO CONTINUE MAPPING IN THE AORTIC CUSPS AND LEFT VENTRICLE. AT THIS POINT, THE CATHETER WAS REMOVED AND EXCHANGED FOR A NEW CATHETER. UPON CONNECTING THE CATHETER AND INSERTING INTO THE AORTA, ANOTHER MAGNETIC SENSOR ISSUE WAS DETECTED ON THE NEW CATHETER IN VOXEL MODE. AT THIS POINT, THE CATHETER WAS TRIED IN PORT SE2 ON THE AMPLIFIER WITH NO CHANGE IN ERROR MESSAGE. NEXT, A NEW CASE WAS OPENED, THE ENSITE X AMPLIFIER WAS RESTARTED AND THE ENSITE DWS WAS RESTARTED TO ENSURE THE ERROR WASN'T A SOFTWARE GLITCH. THE MAGNETIC SENSOR ERROR PERSISTED SO THE CASE CONTINUED SUCCESSFULLY IN NAVX MODE WITHOUT A CONTACT FORCE VECTOR ARROW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502809 TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ABBOTT MEDICAL A-TFSE-DF 10869313 05415067034571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TACTIFLEX ABLATION CATHETER SE