BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 2954105 · Received February 3, 2013

    Report

    Report Number
    2954105
    Event Type
    Injury
    Date Received
    February 3, 2013
    Date of Event
    December 26, 2012
    Report Date
    February 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING DEPLOYMENT OF A 2.0 X 12 MM BALLOON DEPLOYMENT IN THE DISTAL RCA TO CREATE A SMALL CHANNEL, A 4.082 18-MM ION MEDICATED STENT WAS ATTEMPTED TO CROSS THROUGH THE PROXIMAL TORTUOUS RCA, BUT WAS UNABLE. WHILE RETRIEVING BACK THE BALLOON, THE STENT DISLODGED OUT OF THE BALLOON AND STAYED WITHIN THE PROXIMAL CALCIFIED SECTION OF THE RCA. BOSTON SCIENTIFIC POST MARKET SURVEILLANCE HAS SUBMITTED AND RECEIVED RESPONSES TO SEVERAL QUESTIONS PERTAINING TO THIS EVENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEFT HEART CATH, SELECTIVE CORONARY ANGIOGRAM, LEFT VENTRICULAR ANGIOGRAM, AORTIC ROOT ANGIOGRAM PTCA OF RCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45706 * STENT, CORONARY MAF BOSTON SCIENTIFIC ION 14962574

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention UNKNOWN AT THIS TIME