BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM

    MDR report key: 23077672 · Received September 17, 2025

    Report

    Report Number
    3008452825-2025-00460
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 13, 2025
    Report Date
    November 5, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRF
    UDI-DI
    05414734201285
    PMA / PMN Number
    K894500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. NO NONCONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED.

    Description of Event or Problem · 0

    DURING AN ABLATION PROCEDURE, AFTER INSERTION INTO THE PATIENT, THE CATHETER APPEARANCE LOOKED WRONG ON FLUOROSCOPY. THE CATHETER WAS REMOVED AND WAS NOTED TO BE FRACTURED AT THE DISTAL END BETWEEN THE CURVE AND THE SHAFT. 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
    2552533 SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ABBOTT MEDICAL 401430 10856020 05414734201285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown