BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1634755 · Received March 11, 2010

    Report

    Report Number
    2953144-2010-00381
    Event Type
    Malfunction
    Date Received
    March 11, 2010
    Date of Event
    February 11, 2010
    Report Date
    February 15, 2010
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    FGE
    PMA / PMN Number
    K050103
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). 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 ISSUE: PREMATURE, PARTIAL DEPLOYMENT. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE XCEED STENT DELIVERY SYSTEM WOULD NOT ADVANCE IN THE SHEATH AND IT WAS OBSERVED THAT THE STENT WAS EXPOSED APPROX 1-2 MM. THERE WAS NO REPORTED PT EFFECT. 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 INC. NA 710526H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED SHEATH