BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRO ELITE SNARE

    MDR report key: 1432916 · Received May 15, 2009

    Report

    Report Number
    1225894-2009-00001
    Event Type
    Malfunction
    Date Received
    May 15, 2009
    Date of Event
    April 23, 2009
    Report Date
    April 24, 2009
    Manufacturer
    RADIUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    MMX
    PMA / PMN Number
    071457
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT VASCULAR DISTRIBUTES THE EXPRO ELITE SNARE FOR RADIUS MEDICAL. ABBOTT VASCULAR PROVIDES US REGULATORY REPORTING FOR THIS PRODUCT. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. WITHOUT DEVICE ANALYSIS, A SPECIFIC ROOT CAUSE OF THE REPORTED PUNCTURE COULD NOT BE DETERMINED. REVIEW OF 100 UNITS IN INVENTORY HAS SHOWN NO PACKAGING PUNCTURES OR DEFECTS. THIS IS THE FIRST COMPLAINT OF THIS NATURE. PRODUCTS HAVE BEEN POUCHED AND SHIPPED TO CUSTOMERS USING IDENTICAL PACKAGING MATERIALS, COMPONENTRY, PROCESS, AND EQUIPMENT WITHOUT ANY INCIDENTS. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITY WHICH COULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: INNER POUCH PUNCTURED. TIME OF DEVICE MALFUNCTION: DURING UNPACKAGING. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT THE EXPRO ELITE BOX WAS OPENED AND IT WAS NOTICED THAT THE INSIDE STERILE POUCH HAD A PUNCTURE THE SIZE OF A BALLPOINT PEN PUNCTURE. THE OUTER BOX HAD BEEN SEALED AND WAS INTACT. THERE WAS NO PT INVOLVEMENT. THOUGH REQUESTED NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRO ELITE SNARE MMX RADIUS MEDICAL TECHNOLOGIES, INC. NA 08W15076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA