BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VORTEX VX VASCULAR ACCESS PORT

    MDR report key: 1962628 · Received January 11, 2011

    Report

    Report Number
    MW5018992
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    November 30, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED WITH VORTEX PORT THAT HAS FRACTURED AT THE JUNCTION BETWEEN THE CATHETER AND THE PORT. PER SURGERY REPORT, "THE CATHETER DID NOT APPEAR TO FRACTURE UPON REMOVAL, BUT WAS FOUND TO BE FRACTURED AT ITS JUNCTION TO THE INFUSAPORT. AFTER HANDING OFF THE CATHETER, THE REMAINING PORT ITSELF WAS DISSECTED FROM SURROUNDING CAPSULE AND REMOVED INTACT, ASSOCIATED WITH THE SUTURES SECURING THE CATHETER TO THE SUBCUTANEOUS TISSUE AND FASCIA." THE PORT WAS USED 3 TIMES PER WEEK PER PT'S FAMILY FOR IV MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VORTEX VX VASCULAR ACCESS PORT VORTEX PORT LJT ANGIODYNAMICS NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization