BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 2182966 · Received July 28, 2011

    Report

    Report Number
    2134265-2011-03114
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AT TIME OF EVENT: OVER (B)(6) OLD. DEVICE EVALUATED BY MFR.: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 2.0MM X15MM APEX MONORAIL BALLOON WAS BEING USED TO PRE-DILATE AN UNSPECIFIED LESION AND RUPTURED AT NOMINAL PRESSURE THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT'S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895915200 13197028

    Patients

    Seq Age Sex Outcome Treatment
    1