BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER MONORAIL 4.0MM X 8MM

    MDR report key: 4251354 · Received November 5, 2014

    Report

    Report Number
    MW5039021
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 13, 2014
    Report Date
    November 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC CATHETERIZATION STENT CAME OFF BALLOON IN BODY. IT WAS SUCCESSFULLY RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709970 PROMUS PREMIER MONORAIL 4.0MM X 8MM CORONARY STENT SYSTEM MAF BOSTON SCIENTIFIC CORP. H7493352808400 16575725

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention