BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLYETHYLENE ANGIOGRAPHIC CATHETER

    MDR report key: 260752 · Received February 3, 2000

    Report

    Report Number
    1820334-2000-00007
    Event Type
    Other
    Date Received
    February 3, 2000
    Date of Event
    January 6, 2000
    Report Date
    January 6, 2000
    Manufacturer
    COOK INCORPORATED
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    A PULMONARY ANGIOGRAPHIC STUDY WAS BEING PERFORMED. UPON CONTRAST INJECTION VIA A POWER INJECTOR, AN APPARENT PULMONARY ARTERY EXTRAVASATION OCCURRED. THE CATHETER WAS WITHDRAWN AND IT WAS NOTED TO HAVE NO SIDEPORTS. THE USER THOUGHT THEY WERE USING A CATHETER WITH SIDEPORTS. AN INJECTION OF 40CC FOR 20 SECONDS OF OMNIPAQUE 350 WAS USED FOR THE INITIAL ANGIOGRAM. THE RADIOLOGIST DID NOT NOTE ANY OTHER ADVERSE SIGNS OR SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYETHYLENE ANGIOGRAPHIC CATHETER CATHETER DQO COOK INCORPORATED NA F146137

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other