BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD PRO EMBOLIC PROTECTION SYSTEM

    MDR report key: 1213676 · Received October 23, 2008

    Report

    Report Number
    9616695-2008-00150
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NTE
    PMA / PMN Number
    K052454
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIRST EMBOSHIELD PRO DEVICE IS FILED UNDER MFR #9616695-2008-00149. THE THIRD AND FOURTH EMBOSHIELD PRO DEVICES ARE BEING FILED ON SEPARATE MEDWATCH REPORTS. THE DEVICE REPORTED IS AN ABBOTT INTERNATIONAL PRODUCT WHICH IS THE SAME OR SIMILAR TO A DEVICE THAT IS MARKETED DOMESTICALLY. EVALUATION SUMMARY: THE CUSTOMER REPORTED OBSERVING THE LABEL MISMATCH DURING THEIR ADD'L LABELING PROCESS ON FOUR DEVICES. THE LOT HISTORY RECORDS (LHR) WERE REVIEWED FOR BOTH THE REPORTED INNER POUCH LABEL (LOT 511115) AND THE DEVICE CARTON LABEL (LOT 513366). REVIEW OF THE LHRS DID NOT REVEAL ANY NON-CONFORMITIES OR DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE LOTS WERE BUILT FIFTEEN DAYS APART. COMMUNICATIONS WITH THE ABBOTT DISTRIBUTION CENTER IN MAASTRICHT, NETHERLANDS WERE MADE. THERE IS NO INFO SUGGESTING THAT THESE LOTS WERE REWORKED OR RELABELED AT THIS DISTRIBUTION CENTER. THE ABBOTT DISTRIBUTOR IN BRAZIL WAS CONTACTED. A SECONDARY LABEL IS ADDED TO THE DEVICE CARTON ONLY. THE ORIGINAL DEVICE CARTON SEAL REMAINS INTACT. THE INTERNATIONAL AFFILIATE REVIEWED THEIR DOCUMENTS AND NO INFO SUGGESTS THE MISMATCHED LOT NUMBER LABELS OCCURRED DURING THIS SECONDARY LABELING PROCESS. THE DEVICES WERE USED BEFORE INFO OF THE OBSERVED DISCREPANCY WAS REPORTED. THERE WERE NO ADVERSE EVENTS REPORTED FROM THESE CASES. IT MAY BE POSSIBLE THAT THE MIX UP OCCURRED DURING THE CUSTOMER'S PROCESS OF ADD'L LABELING ON THE INNER POUCH. IN ORDER TO ADD LABELS TO THE INNER POUCH, THE INNER POUCH MUST BE REMOVED FROM THE DEVICE CARTON, AND THE DEVICE CARTON SEAL WILL BE BROKEN. A ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED MISMATCHED LOT NUMBER ON INNER POUCH TO DEVICE CARTON.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: POSSIBLE MISLABELING. TIME OF MALFUNCTION: DURING UNPACKAGING. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING UNPACKAGING, THE DISTRIBUTOR OPENED THE SEALED EMBOSHIELD BOXES AND GLUED NEW LABELS ON BOTH THE OUTER BOXES AND INNER POUCHES. THE NEW LABELS INCLUDED THE DISTRIBUTOR'S NAME AND ALSO THE LOT NUMBER. DURING THE PROCESS, THE DISTRIBUTOR NOTICED THAT 4 EMBOSHIELD DEVICES HAD DIFFERENT LOT NUMBERS ON THE INNER AND OUTER PACKAGES. ALTHOUGH AWARE OF THIS DISCREPANCY, THE DISTRIBUTOR SENT THESE DEVICES TO HOSPITALS AND ALL FOUR DEVICES WERE SUCCESSFULLY USED IN PTS. THERE WERE NO ADVERSE PT EFFECTS. THE LOT NUMBERS ON THE INNER PACKAGES IS 511115 (EXP DATE NOV 2009) AND THE LOT NUMBERS IN THE OUTER PACKAGES IS 513366 (EXP DATE DEC 2009). NEITHER THE DEVICES NOR PACKAGING WILL BE RETURNING. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED. THIS SECOND DEVICE WAS USED IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD PRO EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR GALWAY NA 511115

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK EMBOSHIELD PRO| PART 82905| LOT 511115 (X3)