BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH HEMOSTASIS INTRODUCER

    MDR report key: 17328044 · Received July 14, 2023

    Report

    Report Number
    3005334138-2023-00316
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    June 5, 2023
    Report Date
    August 23, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    UDI-DI
    05414734013772
    PMA / PMN Number
    K914090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INFORMATION WAS RECEIVED AND REVIEW IT WAS CONFIRMED THAT THIS EVENT IS A DUPLICATE OF PER-2023-0093693 AND HAS ALREADY BEEN REPORTED UNDER REGULATORY REPORT MDR-2023-26004.

    Description of Event or Problem · 0

    AFTER FURTHER INFORMATION WAS RECEIVED AND REVIEW IT WAS CONFIRMED THAT THIS EVENT IS A DUPLICATE OF PER-2023-0093693 AND HAS ALREADY BEEN REPORTED UNDER REGULATORY REPORT MDR-2023-26004.

    Description of Event or Problem · 0

    POST PROCEDURE, WHEN ATTEMPTING TO REMOVE THE SHEATH FROM THE PATIENT, A PORTION OF THE SHEATH DETACHED AND REMAINED IN THE PATIENT. THE DETACHED PORTION WAS RETRIEVED FROM THE PATIENT BEFORE MIGRATING FURTHER IN THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208020 FAST-CATH HEMOSTASIS INTRODUCER INTRODUCER, CATHETER DYB ST. JUDE MEDICAL 406103 8799559 05414734013772

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention