BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENVER PAK W/ SINGLE VALVED SHUNT

    MDR report key: 496219 · Received November 4, 2003

    Report

    Report Number
    1717671-2003-00002
    Event Type
    Injury
    Date Received
    November 4, 2003
    Report Date
    November 4, 2003
    Manufacturer
    DENVER BIOMEDICAL, INC.
    Product Code
    KPM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SHORTLY AFTER PLACEMENT OF A SINGLE-VALVED ASCITES SHUNT FOR THE MANAGEMENT OF CHYLOUS ASCITES, THE PATIENT WAS FOUND TO HAVE A RIGHT-SIDED CHYLOTHORAX. A VENOGRAM SHOWED THAT THE INFERIOR VENA CAVA WAS PERFORATED AND THAT THE TIP OF THE SHUNT'S VENOUS CATHETER PROTRUDED THROUGH THE PERFORATION, DELIVERING CHYLE DIRECTLY INTO THE CHEST CAVITY. THE CHYLE WAS DRAINED, AND THE SHUNT POSITION WAS REVISED. THE PERFORATION IN THE INFERIOR VENA CAVA SEALED SPONTANEOUSLY AND THE PT AND DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENVER PAK W/ SINGLE VALVED SHUNT PERITONEOVENOUS SHUNT KPM DENVER BIOMEDICAL, INC. 42-2055 6645

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R