BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK, INC.

    MDR report key: 147110 · Received January 27, 1998

    Report

    Report Number
    147110
    Event Type
    Malfunction
    Date Received
    January 27, 1998
    Date of Event
    January 15, 1998
    Report Date
    January 20, 1998
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PERFORMANCE OF SELECTIVE CATHERIZATION OF A BRANCH OF THE SUPERIOR MESENTERIC ARTERY USING A SIMMONS-II SHAPE COOK CATHETER (BEACON TIP), 5 FR. IN DIAMETER, IT WAS NOTED DURING STANDARD MANIPULATION OF THE CATHETER THAT THE TIP SEGMENT HAD DETACHED FROM THE SHAFT OF THE CATHETER. THE TIP SEGMENT (I 2CM LONG) BECAME PERMANENTLY DISLODGED INSIDE A SMALL JEJUNAL ARTERIAL BRANCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK, INC. Implant CATHETER DQO COOK, INC. SIMMONS 2 CATHETER 644468

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other