BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW HOWES

    MDR report key: 1003707 · Received December 28, 2007

    Report

    Report Number
    1003707
    Event Type
    Injury
    Date Received
    December 28, 2007
    Date of Event
    April 25, 2007
    Report Date
    October 2, 2007
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNINTENTIONAL RETAINED GUIDEWIRE. TRIPLE LUMEN LINE PLACED VIA SINGLE STICK INTO RIGHT FEMORAL VEIN WITH OUT COMPLICATION. POST PROCEDURE CHEST-RAY DONE BUT RETAINED GUIDE WIRE NOT IDENTIFIED. FLUID AND MEDICATION ADMINISTRATION VIA CENTRAL LINE. GUIDEWIRE NOT IDENTIFIED DESPITE SERIAL CHEST X-RAYS, ALTHOUGH VISIBLE UPON RETROSPECTIVE REVIEW ON MOST FILMS. PERCUTANEOUS REMOVAL BY INTERVENTIONAL RADIOLOGIST REQUIRED AS J-TIPPED INTRODUCER GUIDEWIRE WAS FOUND LODGED IN THE PT'S VENOUS SYSTEM, SPANNING THE ENTIRE LENGTH OF THE CENTRAL VENOUS SYSTEM. THE J-TIP WAS LODGED IN THE LOWER ASPECT OF THE RIGHT INTERNAL JUGULAR VEIN AND THE STRAIGHT TIP LOCATED BELOW THE RIGHT INGUINAL LIGAMENT. PATIENT SUBSEQUENTLY EXPIRED FROM UNDERLYING ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW HOWES MULTI LUMEN CVP KIT DQO ARROW INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R