BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4F MICRO INTRODUCER KIT

    MDR report key: 506950 · Received January 12, 2004

    Report

    Report Number
    1625425-2004-00001
    Event Type
    Injury
    Date Received
    January 12, 2004
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DYB
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THERE WAS A PROBLEM WITH THE DILATOR HUB DETACHING WHEN REMOVING FROM PT. (THE DOCTOR WAS OBTAINING ACCESS FOR A PACEMAKER PROCEDURE AND INSERTED THE DILATOR. WHEN THE DOCTOR WAS REMOVING THE DILATOR THE HUB BROKE OFF AND THE REST OF IT WAS STILL IN THE PT'S SHOULDER. THE DOCTOR WAS ABLE TO CUT AROUND THE INSERTION SITE AND REMOVE IT. A CUTDOWN WAS ALREADY PLANNED THEREFORE NO UNNECESSARY SURGICAL INTERVENTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4F MICRO INTRODUCER KIT INTRODUCER KIT DYB ARGON MEDICAL DEVICES INC. * 99381416

    Patients

    Seq Age Sex Outcome Treatment
    1 *