BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2010535 · Received February 25, 2011

    Report

    Report Number
    2010535
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    UNABLE TO PASS WIRE THROUGH THE HUB FORWARDS OR BACKWARDS. NEVER WENT INTO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC 1009547-23B 0100841

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR