BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1083352 · Received July 28, 2008

    Report

    Report Number
    2953144-2008-01240
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 8, 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
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. BECAUSE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, NO ROOT CAUSE FOR THE REPORTED EXPERIENCE CAN BE DETERMINED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURE, PARTIAL DEPLOYMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN THE XCEED STENT DELIVERY SYSTEM (SDS) WAS BACK LOADED ON THE GUIDE WIRE. THE DEVICE WAS REMOVED AND PLACED ON THE TABLE WITH THE SDS TIP TOUCHING THE TABLE BEFORE THE REST OF THE DEVICE. THE THUMB LOCK WAS NOT MOVED. IT WAS NOTICED THAT THE FIRST TWO ROWS OF STRUTS WERE DEPLOYED. THIS OCCURRED OUTSIDE OF THE BODY AND THERE WAS NO ADVERSE PT EFFECT. THE PROCEDURE WAS COMPLETED USING ANOTHER EXCEED STENT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    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 45090

    Patients

    Seq Age Sex Outcome Treatment
    1 STORK GUIDE WIRE