BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOJET AVX

    MDR report key: 6903651 · Received September 29, 2017

    Report

    Report Number
    MW5072539
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    September 27, 2017
    Report Date
    September 27, 2017
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ANGIOJET CATHETER MALFUNCTION DURING FISTULA THROMBECTOMY. CATHETER SET UP PER PROTOCOL. CATHETER PLACED ACROSS THROMBUS. ATTEMPTED TO EXTRACT THROMBUS AND THE CATHETER PLUNGER FILLED WITH HEPARINIZED SALINE AND STARTED LEAKING INTO THE ANGIOJET MACHINE. CATHETER WAS REMOVED AND SWITCHED WITH A SECOND CATHETER. THIS MALFUNCTION OCCURRED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686019 ANGIOJET AVX EMBOLECTOMY CATHETER DXE BOSTON SCIENTIFIC 20266255
    686020 ANGIOJET AVX EMBOLECTOMY CATHETER DXE BOSTON SCIENTIFIC 19047261

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention