BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE TRIMMER KP+T

    MDR report key: 409584 · Received August 5, 2002

    Report

    Report Number
    2953144-2002-00087
    Event Type
    Malfunction
    Date Received
    August 5, 2002
    Date of Event
    July 10, 2002
    Report Date
    July 10, 2002
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ACHIEVED ARTERIOTOMY CLOSURE WITH THE CLOSER 6 FR. DEVICE FOLLOWING AN INTERVENTION PROCEDURE. IT WAS REPORTED THAT AFTER ADVANCING THE KNOT, THE PHYSICIAN WAS UNABLE TO LOAD THE SUTURE TRIMMER ON THE SUTURE. IT WAS THEN NOTICED THAT THE BLACK TIP OF THE SUTURE TRIMMER WAS NOT IN COMPLETE ALIGNMENT. THE PHYSICIAN TRIED TO ALIGN THE SUTURE IN THE DIRECTION OF THE TIP AND THEN THE TIP WAS REPORTED TO "COME OFF." THE SUTURE TRIMMER WAS NEVER LOADED ON THE SUTURE AND WAS NOT ADVANCED BELOW THE SKIN LINE. THE SNARED KNOT POSITIONER WAS THEN USED TO CINCH THE KNOT. A SCALPEL WAS USED TO TRIM THE SUTURE. THERE WAS NO REPORT OF AN ADVERSE PATIENT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE TRIMMER KP+T KNOT PUSHER WITH SUTURE TRIMMER MGB PERCLOSE, INC. NA 83080-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other