BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE

    MDR report key: 22645102 · Received July 29, 2025

    Report

    Report Number
    3008452825-2025-00373
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 8, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRF
    UDI-DI
    05414734201438
    PMA / PMN Number
    K151622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6. ONE 6F, QUADRIPOLAR, JSN, SUPREME EP CATHETER WAS RECEIVED FOR EVALUATION. THE SHAFT OF THE CATHETER SHAFT WAS NOTED TO BE FRACTURE AT THE GRAY/BLACK SHAFT BOND JOINT.

    Description of Event or Problem · 0

    DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN ADVANCING THE CATHETER, IT WAS NOTED TO BE DIFFICULT TO MANEUVER. THE CATHETER WAS REMOVED FROM THE PATIENT, AND A FRACTURE WAS FOUND ON PART OF THE CATHETER. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887606 SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ABBOTT MEDICAL 401451 10786617 05414734201438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown