BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYETHYLENE ANGIOGRAPHIC CATHETER

    MDR report key: 622324 · Received July 21, 2005

    Report

    Report Number
    1820334-2005-00198
    Event Type
    Injury
    Date Received
    July 21, 2005
    Date of Event
    June 1, 2005
    Report Date
    June 22, 2005
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CATHETER WAS PLACED FOR THE PTGBD DUE TO ACUTE CHOLECYSTITIS IN 2005. FORTY DAYS AFTER PLACEMENT WHEN THE PHYSICIAN WAS CHANGING THE DRESSING, HE NOTICED THE DISTAL PORTION OF THE CATHETER HAD SEPARATED, MIGRATING INTO THE LIVER. THE NEXT DAY THE SEPARATED PORTION WAS SURGICALLY REMOVED, RESULTING IN THE SCHEDULED LAPAROTOMY BEING RESCHEDULED.

    Description of Event or Problem · 1

    THE CATHETER WAS PLACED FOR THE PTGBD DUE TO ACUTE CHOLECYSTITIS ON APRIL 2005. ON JUNE 2005, (40 DAYS AFTER PLACEMENT) WHEN THE PHYSICIAN WAS CHANGING THE DRESSING, HE NITICED THE DISTAL PORTION OF THE CATHETER HAD SEPERATED, MIGRATING INTO THE LIVER. ON JUNE 2005, THE SEPERATED PORTION WAS SURGICALLY REMOVED, RESULTING IN THE SCHEDULED LAPOROTOMY BEING RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYETHYLENE ANGIOGRAPHIC CATHETER CATHETER DQO COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention