BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW PICC KIT WITH PLACEMENT WIRE

    MDR report key: 1210906 · Received October 22, 2008

    Report

    Report Number
    MW5008739
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 20, 2008
    Manufacturer
    ARROW INTERNATIONAL, INC,
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GUIDEWIRE FROM (3 FR) PICC LINE INSERTION HAD EMBOLIZED TO THE MAIN PULMONARY ARTERY, WITH A PORTION EXTENDING INTO THE RIGHT VENTRICLE AND RIGHT ATRIUM. GUIDEWIRE REMOVED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW PICC KIT WITH PLACEMENT WIRE PERIPHERALLY INSERTED CENTRAL CATHETER KIT WITH PLACEMENT WIRE LJS ARROW INTERNATIONAL, INC, NA RF7089290

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention