BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE TRIMMER KP+T

    MDR report key: 485419 · Received September 16, 2003

    Report

    Report Number
    2953144-2003-00209
    Event Type
    Malfunction
    Date Received
    September 16, 2003
    Date of Event
    August 12, 2003
    Report Date
    August 22, 2003
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF A BROKEN TIP AFTER REMOVAL FROM THE PT. THE ARTERIOTOMY WAS CLOSED WITH A PERCLOSE A-T DEVICE. THE OPERATOR WAS ATTEMPTING TO DELIVER THE KNOT WITH THE SUTURE TRIMMER. IT WAS REPORTED THAT THE KNOT WAS "NOT TRAVELING DOWN THE SUTURE AS IT SHOULD." THE OPERATOR DECIDED TO REMOVE THE SUTURE FROM THE SUTURE TRIMMER. UPON REMOVAL FROM THE TISSUE TRACT, IT WAS NOTED THAT THE TIP WAS SEPARATING FROM THE REST OF THE DEVICE. THE BROKEN PIECE WAS OUTSIDE OF THE PT. A SECOND DEVICE WAS USED TO DELIVER THE KNOT WITH SUCCESS. THE ARTERIOTOMY WAS CLOSED AND HEMOSTASIS WAS ACHIEVED. THE PT WAS DISCHARGED. THERE WAS NO REPORT OF AN ADVERSE PT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE TRIMMER KP+T SUTURE MEDIATED CLOSURE MGB PERCLOSE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other PERCLOSE A-T DEVICE LIST.