BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC GREENFIELD FILTER

    MDR report key: 2243943 · Received September 6, 2011

    Report

    Report Number
    MW5022158
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 11, 2011
    Report Date
    September 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC GREENFIELD FILTER DID NOT DEPLOY. SURGEON PLACED A SECOND GREENFIELD FILTER AND THEN RETRIEVED THE UNDER DEPLOYED GREENFIELD FILTER WITH THE SAME SNARE. MFR NOTIFIED AND CAME DOWN TO SPEAK WITH OUR RISK MGMT AND THE SURGEON. HAD POTENTIAL FOR SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC GREENFIELD FILTER GREENFIELD FILTER TITANIUM JUGL DTK BOSTON SCIENTIFIC 13666258

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other