BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1881667 · Received October 25, 2010

    Report

    Report Number
    2134265-2010-04844
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    July 6, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE HYPOTUBE. THE BREAK WAS LOCATED AT 19.2CM DISTAL TO THE STRAIN RELIEF. MICROSCOPIC EXAMINATION OF THE BREAK SITE FOUND THAT THE BREAK OCCURRED AS A RESULT OF A SEVERE KINK THAT DEVELOPED IN THE SHAFT. A DETAILED EXAMINATION OF THE BALLOON FOUND THAT THE BALLOON HAD BEEN INFLATED AND WAS NOT REFOLDED. NO STENT WAS RECEIVED WITH THE DEVICE FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H749389388250 0011467730

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR