BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC?

    MDR report key: 3896814 · Received June 26, 2014

    Report

    Report Number
    2134265-2014-03618
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED AN EPIC STENT DELIVERY SYSTEM (SDS) OUTSIDE AN OPENED EPIC INNER PACKAGING POUCH. THE BATCH NUMBER ON THE PACKAGING MATCHED THE REPORTED BATCH NUMBER. THERE WAS A LOOSE CURLY PIECE OF HAIR IN THE PACKAGING ON THE PROXIMAL END OF THE POUCH. THERE WAS NO DAMAGE TO THE SDS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    DURING UNPACKAGING OF THE DEVICE, A HAIR WAS FOUND WITHIN THE SEALED PACKAGING OF A 7X60X75 EPIC STENT PRIOR TO OPENING. THE DEVICE WAS NOT USED IN THE PROCEDURE.

    Description of Event or Problem · 1

    DURING UNPACKING OF THE DEVICE, A HAIR WAS FOUND WITHIN THE SEALED PACKAGING OF A 7X60X75 EPIC STENT PRIOR TO OPENING. THE DEVICE WAS NOT USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374014 EPIC? STENT, ILIAC NIO BOSTON SCIENTIFIC - MAPLE GROVE H74939054076070 16719519

    Patients

    Seq Age Sex Outcome Treatment
    1