BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK INC

    MDR report key: 538565 · Received August 6, 2004

    Report

    Report Number
    538565
    Event Type
    Malfunction
    Date Received
    August 6, 2004
    Date of Event
    July 30, 2004
    Report Date
    August 6, 2004
    Manufacturer
    COOK SURGICAL
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004, A DUAL HICKMAN CATHETER WAS INSERTED USING A LEFT SUBCLAVIAN APPROACH. UNFORTUNATELY THIS CATHETER BECAME DISRUPTED 7 DAYS LATER. THE SURGEON SERVICE WAS CONTACTED AND ASKED TO REMOVE THE CATHETER AND INSERT A NEW DEVICE. THE CATHETER PLACED WAS NOTED TO EXIT ALONG THE LEFT ANTERIOR AXILLARY LINE LATERAL TO THE BREAST. THE CATHETER WAS CUT OFF DISTAL TO THE EXIT SITE. A SAME CALIBER J WIRE WAS OBTAINED. THE INSERTION SITE JUST BELOW THE CLAVICLE WAS REOPENED. THE CATHETER WAS PULLED FROM THE EXIT SITE TO THE INSERTION SITE. AT THIS POINT, MULTIPLE ATTEMPTS AT PASSING THE WIRE THROUGH THE DUAL LUMEN CATHETER WERE ULTIMATELY UNSUCCESSFUL. THE WIRE COULD BE ADVANCED UNDER DIRECT FLUOROSOCPIC CONTROL INTO THE CENTRAL CIRCULATION, BUT NOT OUT THE TIP OF THE CATHETER. AFTER MULTIPLE ATTEMPTS, IT WAS FELT THAT THE CATHETER SHOULD BE REMOVED AND A NEW INSERTION ATTEMPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK INC DOUBLE LUMEN CATHETER SET DQO COOK SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other