BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH¿ CATH LOCK¿ HEMOSTASIS INTRODUCER

    MDR report key: 18681029 · Received February 9, 2024

    Report

    Report Number
    3005334138-2024-00051
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 27, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 LEAK REMAINS UNKNOWN.

    Description of Event or Problem · 0

    DURING THE ELECTROPHYSIOLOGY PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284972 FAST-CATH¿ CATH LOCK¿ HEMOSTASIS INTRODUCER INTRODUCER, CATHETER DYB ST. JUDE MEDICAL 406724 7905519

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male