BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1714176 · Received June 4, 2010

    Report

    Report Number
    MW5016222
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    April 13, 2010
    Report Date
    June 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC CORONARY/INTERVENTIONAL CARDIOLOGY DIVISION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT A CARDIAC CATHETERIZATION FOR PROGRESSIVE HEART FAILURE. RESULTS REVEALED A SIGNIFICANT LEFT CIRCUMFLEX LESION. THE PT HAD AN ANGIOPLASTY AND 2 STENTS WERE PLACED. UPON WITHDRAWAL OF THE WIRE 3-4 MM OF THE DISTAL PORTION OF THE WIRE BROKE OFF IN 2 SEGMENTS. ONE SEGMENT WAS RETAINED IN PLACE WITH ANOTHER STENT POSITIONED OVER THE WIRE, AND THE OTHER PIECE REMAINS IN THE DISTAL PORTION OF THE CIRCUMFLEX BECAUSE IT WAS DETERMINED TO BE TOO DETRIMENTAL TO THE PT TO HAVE IT REMOVED -APPROX 1/2 MM-. THIS WAS DETERMINED NOT TO CAUSE ADD'L HARM TO THE PT. THE WIRE WAS PERCEIVED TO BREAK DUE TO MANIPULATION IN A TIGHT LESION, HOWEVER, IT WAS DETERMINED THE LESION WAS SUITABLE FOR ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC LUGE .014" MODERATE SUPPORT GUIDEWIRE DQX BOSTON SCIENTIFIC CORONARY/INTERVENTIONAL CARDIOLOGY DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR