BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA THIN DIAMOND/SDA BALLOONS

    MDR report key: 627215 · Received August 10, 2005

    Report

    Report Number
    627215
    Event Type
    Injury
    Date Received
    August 10, 2005
    Date of Event
    July 19, 2005
    Report Date
    August 9, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    HI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING FISTULOGRAM AND DECLOTTING OF THEIR ARTERIO BENOUS GRAFT. BLOOD VESSEL TORE AND HEMOSTASIS ATTEMPTED IN ANGIOGRAPHY BUT FAILED. SURGEON CONSULTED AND PATIENT TAKEN TO THE OPERATING ROOM FOR OPEN REPAIR OF THE BLOOD VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA THIN DIAMOND/SDA BALLOONS BALLOON ANGIOCATH DQO BOSTON SCIENTIFIC 17-655 *
    2 ULTRA THIN DIAMOND/SDA BALLOONS BALLOON ANGIOCATH DQO BOSTON SCIENTIFIC 17686 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L