BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VASCULAR SD

    MDR report key: 1052507 · Received May 22, 2008

    Report

    Report Number
    2134265-2008-01481
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A RENAL STENT PLACEMENT PROCEDURE, THE PACKAGE WAS COMPROMISED. UPON REMOVING THE BOX CONTAINING THE EXPRESS VASCULAR PMTD 5.0MM X 15MM X 90CM STENT DELIVERY SYSTEM FROM THE SHELF, IT WAS NOTED THAT "STICKY TAPE" WAS ON THE "BOTTOM ACCESS FLAP OF THE EXTERIOR BOX". THE INNER POUCH CONTAINING THE DEVICE WAS REMOVED FROM THE BOX AND FOUND TO BE PREVIOUSLY OPENED. THE DEVICE WAS NOT USED DURING THE PROCEDURE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S STATUS IS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS VASCULAR SD NA NIN BOSTON SCIENTIFIC NA 83460585

    Patients

    Seq Age Sex Outcome Treatment
    1