BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDIS CORPORATION

    MDR report key: 445489 · Received February 28, 2003

    Report

    Report Number
    445489
    Event Type
    Malfunction
    Date Received
    February 28, 2003
    Date of Event
    January 18, 2003
    Report Date
    January 28, 2003
    Manufacturer
    CORDIS CORPORATION/QUALITY CONTROL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    DURING TRANS HEPATIC INTRAPORTAL SHUNT (TIPS) PROCEDURE, WHILE ADVANCING CATHETER THROUGH SHEATH, THE END OF SHEATH BROKE OFF AND IMPLANTED INTO STENT WHICH IS PLACED IN THE PORTAL VEIN. WHEN CONTRAST WAS INJECTED THROUGH STENT, TIP WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS CORPORATION BRITE TIP SHEATH 9FR INTRODUCER DYB CORDIS CORPORATION/QUALITY CONTROL UNK X0802954

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other NONE KNOWN.