BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK VITAL PORT

    MDR report key: 22426 · Received October 26, 1994

    Report

    Report Number
    1056436-1994-00001
    Event Type
    Injury
    Date Received
    October 26, 1994
    Date of Event
    January 5, 1994
    Report Date
    January 6, 1994
    Manufacturer
    COOK PACEMAKER CORP.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED FOR ROUTINE EXPLANT OF PORT, THERAPY WAS FINISHED. SURGEON REMOVED PORT AND NOTICED CATHETER WAS SHORTER THAN NORMAL. SURGEON SUSPECTED DISTAL END OF CATHETER SHEARED. X-RAY CONFIRMED - APPROXIMATELY TWO INCHES OF CATHETER REMAINED IN HEART OF PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK VITAL PORT Implant INDWELLING CATHETER DQO COOK PACEMAKER CORP. 7110

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention