BEUDAMED
    FDA Adverse Event Summary report: N

    APEX MONORAIL

    MDR report key: 2020659 · Received March 1, 2011

    Report

    Report Number
    2020659
    Date Received
    March 1, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PTCA PROCEDURE, BALLOON RUPTURED WHILE ATTEMPTING TO BREAK CALCIFIED PLAQUE. THIS BALLOON FRACTURED AT SHAFT LEAVING THE DISTAL SEGMENT IN THE CORONARY ARTERY. ATTEMPTS TO RETRIEVE WERE UNSUCCESSFUL DUE TO A PREVIOUSLY IMPLANTED STENT THAT OBSTRUCTED THE REMOVAL. SENT FOR CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) FOR RESTORATION OF LEFT ANTERIOR DESCENDING ARTERY (LAD). PREVIOUS BALLOONS USED DURING PROCEDURE ALSO RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 3859-1222 14063484

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR