BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK MEDICAL

    MDR report key: 3060156 · Received April 10, 2013

    Report

    Report Number
    MW5029742
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 10, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESIDENTS WERE ATTEMPTING ARTERIAL LINE INSERTION IN LEFT RADIAL ARTERY. MICROPUNCTURE KIT UTILIZED WITHOUT INCIDENT UNTIL THE GUIDE WIRE WAS TO BE REMOVED. THE GUIDE WIRE WAS PARTIALLY REMOVED WHEN RESISTANCE WAS FELT AND THE GUIDE WIRE WAS DISCOVERED TO BE FRAYED. VASCULAR RESIDENTS ATTEMPTED TO REMOVE THE WIRE WITH CONCERN REGARDING THE RESISTANCE FELT. THEY PREPARED FOR A CUT DOWN AND AFTER STARTING AND INITIAL INCISION, THE WIRE WAS ABLE TO BE REMOVED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150080 COOK MEDICAL MICROPUNCTURE INTRODUCER SET DYB COOK, INC. MPIS-501-SST 3898688

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR