BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 14515545 · Received May 26, 2022

    Report

    Report Number
    3008452825-2022-00431
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    May 16, 2022
    Report Date
    November 9, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    UDI-DI
    05414734201421
    PMA / PMN Number
    K002976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 5F, QUADRIPOLAR, JSN, SUPREME EP CATHETER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THE BLACK CONNECTOR PLUG BACK NUT WAS FRACTURED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, WHEN ATTEMPTING TO EXCHANGE THE DEVICE AND PULLING ON THE CATHETER, THE SHAFT BROKE INTO 2 PIECES. THERE WERE NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2754075 SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL 401450 8352381 05414734201421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other