BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR

    MDR report key: 1357860 · Received February 7, 2007

    Report

    Report Number
    1357860
    Event Type
    Malfunction
    Date Received
    February 7, 2007
    Date of Event
    November 28, 2006
    Report Date
    November 28, 2006
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POST STENT PLACEMENT WHILE REMOVING DELIVERY DEVICE, THE DEVICE BECAME "STUCK" ON TERUMO WIRE. UNABLE TO RETRIEVE WITH MODERATE EFFORT. WIRE STABILIZED AND SIGNIFICANT EFFORT USED. STAFF NOTED A "POP" AND DEVICE BECAME EASY TO REMOVE FROM WIRE. IT WAS NOTED THAT APPROXIMATELY 4" OF INNER LAYER OF DEVICE WAS LEFT ON WIRE. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR XCEED BILIARY STENT SYSTEM FGE ABBOTT VASCULAR 7MMX100MM 44190-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR