BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1230412 · Received November 7, 2008

    Report

    Report Number
    2134265-2008-04262
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTION PROCEDURE, A SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED RIVA AND FIRST DIAGONAL. THE 2.5X15MM APEX MONORAIL BALLOON CATHETER CROSSED THE TARGET LESION AND THE SHAFT OF THE DEVICE BROKE. THE DEVICE WAS SUCCESSFULLY REMOVED AS A SYSTEM FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED WITH THE PATIENT'S CONDITION LISTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL NA LOX BOSTON SCIENTIFIC 2.5X15MM 0011618763

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR