BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 810349 · Received October 13, 2005

    Report

    Report Number
    810349
    Event Type
    Other
    Date Received
    October 13, 2005
    Date of Event
    August 31, 2005
    Report Date
    September 6, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    TAXUS EXPRESS STENT SYSTEM UTILIZED IN PT WITH CAD. THE BALLOON RUPTURED AT 4 ATM, LONG BEFORE NOMINAL ATM REACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC 3.0X28 TAXUS EXPRESS MONORAIL NIQ BOSTON SCIENTIFIC * 7415265

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other