BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOKE INC

    MDR report key: 512262 · Received February 18, 2004

    Report

    Report Number
    512262
    Event Type
    Injury
    Date Received
    February 18, 2004
    Date of Event
    December 9, 2003
    Report Date
    December 31, 2003
    Manufacturer
    COOKE, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A PEDIATRIC CARDIAC CATHETERIZATION, THE COOK CATHETER TIP BROKE IN TWO PLACES WHILE IN THE FEMORAL ARTERY. THE PIECES WERE UNABLE TO BE RETRIEVED OR REMOVED BY THE INTERVENTIONAL RADIOLOGISTS; HOWEVER, THEY WERE ABLE TO MOVE THE PIECES FROM THE FEMORAL ARTERY TO THE INFERIOR GLUTERAL ARTERY BRANCH. THE CHILD HAS BEEN STABLE FOLLOWING THE PROCEDURE. (THE STERILIZATION DATE OF THE CATHETER HAD EXPIRED, AND THE UNUSED CATHETER WAS RE-STERILIZED BY A REPROCESSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOKE INC ANGIOGRAPHIC CATHETER JL3, 5FR X 025 X 80CM DQO COOKE, INC. HNBR502580PNJ *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention