BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1860729 · Received October 7, 2010

    Report

    Report Number
    2134265-2010-04525
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    June 4, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE TIP OF THE DEVICE HAD DETACHED AND WAS MISSING. MICROSCOPIC EXAMINATION OF THE BREAK SITE FOUND THAT THE EXTRUSION WAS STRETCHED AT THE SITE OF THE BREAK. A 0.015INCH SIZE MANDREL WAS INSERTED FROM THE PORT, THROUGH THE GUIDEWIRE LUMEN AND EXITED OUT THROUGH THE SITE OF THE BREAK WITH NO RESTRICTIONS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS TH EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT WAS UNABLE TO BE LOADED ON A GUIDE WIRE. THE LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A LIBERTE BARE 24MM X 3.5MM STENT WAS UNABLE TO BE LOADED ON ANOTHER MANUFACTURER'S GUIDE WIRE. THE EXIT PORT ON THE STENT CATHETER WAS BLOCKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. PATIENT STATUS REPORTED AS STABLE. HOWEVER, PRODUCT ANALYSIS REVEALED CATHETER TIP DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893824350 0012740018

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR GUIDE WIRE: 0.014 (B)(4)