BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 2132664 · Received June 10, 2011

    Report

    Report Number
    MW5020990
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A BOSTON SCIENTIFIC 2.5 X 30 NC QUANTUM APEX BALLOON, LOT NUMBER UNK, GOT STUCK AND COULD NOT BE REMOVED FROM THE BODY AFTER SEVERAL ATTEMPTS AND THE PT COMPLAINING OF CHEST PAIN. THE SHEATH WAS SUTURED TO THE RIGHT GROIN AND THE PT WAS SENT DIRECTLY TO SURGERY. THE BALLOON WAS SUCCESSFULLY REMOVED AND A BYPASS GRAFT TO RCA WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC 2.5 X 30 NC QUANTUM APEX BALLOON LOX BOSTON SCIENTIFIC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability