BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D

    MDR report key: 23735213 · Received December 5, 2025

    Report

    Report Number
    3008452825-2025-00639
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    September 4, 2025
    Report Date
    December 5, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    OAE
    UDI-DI
    05415067027689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE UNI-DIRECTIONAL, CURVE D, TACTICATH SENSOR ENABLED CONTACT FORCE ABLATION CATHETER WAS RECEIVED FOR EVALUATION. THE REPORTED CONTACT FORCE ISSUE WAS CONFIRMED. OPTICAL FIBERS 1 AND 2 DID NOT MEET SPECIFICATIONS FOR OPTICAL PROPERTIES AND NO CONTACT FORCE WAS DISPLAYED WHEN THE CATHETER WAS CONNECTED TO THE TACTISYS QUARTZ UNIT. FURTHER INVESTIGATION REVEALED OPTICAL FIBERS 1 AND 2 WERE FRACTURED WITHIN THE DISTAL SHAFT, CONSISTENT WITH THE DETECTED OPTICAL SIGNAL ISSUE AND THE REPORTED ISSUE. MICROSCOPIC INSPECTION OF THE DISTAL SHAFT REVEALED A FRACTURE DISTAL TO PULL RING WITH BRAIDING PROTRUDING THROUGH FRACTURE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE FRACTURED OPTICAL FIBER REMAINS UNKNOWN.

    Description of Event or Problem · 0

    THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP WITH A PROTRUDING COMPONENT DURING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041708 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation OAE ABBOTT MEDICAL A-TCSE-D 10601470 05415067027689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown