BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1011312 · Received March 7, 2008

    Report

    Report Number
    2953144-2008-00122
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ABBOTT VASCULAR, REDWOOD CITY
    Product Code
    FGE
    PMA / PMN Number
    K050103
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PARTIAL DEPLOYMENT. TIME OF MALFUNCTION: DURING UNPACKAGING. SYMPTOMS/AE: NA. IT WAS REPORTED THAT WHEN THE DEVICE WAS PULLED OUT OF THE BOX, THE FIRST FEW MILLIMETERS OF THE DEVICE WERE ALREADY DEPLOYED. THERE WAS NO PT INVOLVEMENT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM FGE ABBOTT VASCULAR, REDWOOD CITY NA 58089-6H

    Patients

    Seq Age Sex Outcome Treatment
    1