BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3822476 · Received May 21, 2014

    Report

    Report Number
    2134265-2014-02925
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE LIBERTE STENT DELIVERY SYSTEM (SDS) WAS RECEIVED IN A SEALED INNER PACKAGING POUCH AND OPENED SHELF BOX. THERE WAS A FIBROUS FM INSIDE THE PACKAGING FLOATING FREELY. THE FM WAS NOT IN THE SEAL OR STUCK ON THE DEVICE. IT COULD NOT BE DETERMINED WHERE THE FM ORIGINATED FROM; HOWEVER, THE FM WAS DETERMINED TO BE ACCEPTABLE PER THE FM INSPECTION PROCESS. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS USER PREFERENCE ISSUE AS THE PRODUCT MET SPECIFICATION BUT THE USER WAS REPORTEDLY DISSATISFIED WITH THE FUNCTION, PERFORMANCE, OR APPEARANCE OF THE PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND INSIDE THE SEALED POUCH. DURING A CONTROL PROCEDURE PERFORMED BY THE COMPETENT AUTHORITY, ¿FILAMENTS OF SUSPICIOUS ORIGIN" WERE DISCOVERED INSIDE THE SEALED INTACT INTERNAL POUCH OF THE 2.50MM X 16MM LIBERTÉ STENT DELIVERY SYSTEM. IT WAS BELIEVED THAT THE FILAMENTS WERE HAIR OR FIBERS. THERE WAS NO PROCEDURE OR PATIENT INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND INSIDE THE SEALED POUCH. DURING A CONTROL PROCEDURE PERFORMED BY THE COMPETENT AUTHORITY, ¿FILAMENTS OF SUSPICIOUS ORIGIN" WERE DISCOVERED INSIDE THE SEALED INTACT INTERNAL POUCH OF THE 2.50MM X 16MM LIBERTÉ¿ STENT DELIVERY SYSTEM. IT WAS BELIEVED THAT THE FILAMENTS WERE HAIR OR FIBERS. THERE WAS NO PROCEDURE OR PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303851 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893816250 16666005

    Patients

    Seq Age Sex Outcome Treatment
    1