BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE INTRODUCER SET

    MDR report key: 3021185 · Received March 21, 2013

    Report

    Report Number
    3021185
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 21, 2013
    Manufacturer
    COOK MEDICAL INCORPORATED
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE PHYSICIAN WAS OBTAINING ACCESS TO THE LEFT VEIN FOR AN ICD IMPLANT. A MICROPUNCTURE NEEDLE AND WIRE WERE USED. THE MICROPUNCTURE WIRE FRAYED APART INSIDE THE NEEDLE WHICH WAS INSIDE LEFT SUBCLAVIAN VEIN. THE PHYSICIAN WAS ABLE TO REMOVE THE NEEDLE AND MOST OF THE WIRE. PART OF THE MICROPUNCTURE WIRE REMAINED INSIDE THE PATIENT. A VASCULAR SURGEON WAS CALLED TO ASSIST IN THE REMOVAL OF THE PORTION OF THE MICROPUNCTURE WIRE THAT CAME APART INSIDE THE PATIENT. SURGEON WAS SUCCESSFUL IN REMOVING THE SMALL PIECE OF MICROPUNCTURE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118900 MICROPUNCTURE INTRODUCER SET INTRODUCER, CATHETER DYB COOK MEDICAL INCORPORATED MPIS-501-NT-SST 4028659

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR