BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 23393096 · Received October 27, 2025

    Report

    Report Number
    3008452825-2025-00531
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 1, 2025
    Report Date
    February 10, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    OAE
    UDI-DI
    05415067034670
    PMA / PMN Number
    P220013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D9, G3, H2, H3, H6. ONE UNI-DIRECTIONAL, CURVE F, TACTIFLEX ABLATION CATHETER, SENSOR ENABLED WAS RECEIVED FOR EVALUATION. THE REPORTED AMPERE RECOGNITION AND IMPEDANCE ISSUE COULD NOT BE CONFIRMED. ELECTRODE 1 AND THE TIP THERMOCOUPLE MET SPECIFICATIONS DURING ELECTRICAL TESTING WITH NO OPEN OR SHORT CIRCUITS DETECTED. IN ADDITION, THE TIP THERMOCOUPLE TEMPERATURE READING INCREASED WITH EXPOSURE TO HEAT. 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 SVT PROCEDURE, COMMUNICATION AND IMPEDANCE ISSUES WITH THE CATHETER RESULTED IN A PROCEDURAL DELAY. THE ABLATION CATHETER WAS REMOVED FOLLOWING BEST PRACTICES AND CONNECTED TO THE COOLPOINT PUMP, THE TACTISYS, AND THE ENSITE X SE PORT. THE CATHETER WAS FLUSHED AND INSPECTED BEFORE INSERTING INTO THE PATIENT. ON THE MAPPING SYSTEM, THE CATHETER WAS VISUALIZED, THE CATHETER SIGNALS WERE SEEN, AND THE CONTACT FORCE WAS ABLE TO BE ZEROED. HOWEVER, IT WAS NOTED ON THE GENERATOR METRICS THAT THE IMPEDANCE READINGS WERE 200 OHMS. THE AMPERE MESSAGE STATED, "CATHETER NOT CONNECTED." THE TACTIFLEX RF CABLE (FROM TACTISYS TO AMPERE) WAS REPLACED AND THE IMPEDANCE NOW READ 999 ON THE MAPPING SYSTEM AND THE AMPERE CONTINUED TO NOT RECOGNIZE THE CATHETER CONNECTION. THE AMPERE AND TACTISYS WERE BOTH POWER CYCLED WITH NO RESOLUTION. THE AMPERE WAS THEN REPLACED BUT THE ISSUE PERSISTED. THE CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. THIS REPORT INCLUDES AN UPDATED ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260099 TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ABBOTT MEDICAL A-TFSE-F 10758992 05415067034670

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female