BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE TRIMMER KP+T

    MDR report key: 349056 · Received August 21, 2001

    Report

    Report Number
    2953144-2001-00148
    Event Type
    Malfunction
    Date Received
    August 21, 2001
    Date of Event
    July 23, 2001
    Report Date
    July 23, 2001
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER DEPLOYING A CLOSER TSL 6 FR. DEVICE, FOLLOWING A DIAGNOSTIC CATHETERIZATION PROCEDURE, THE SUTURE TRIMMER WAS USED TO ADVANCE THE KNOT. UPON ADVANCEMENT, THE SUTURE TRIMMER APPARENTLY CAUGHT ON THE SUTURE AND WAS DIFFICULT TO REMOVE. THE PHYSICIAN PULLED THE SUTURE TRIMMER OUT OF THE GROIN SUCCESSFULLY. THE PERCLOSE REP WAS PRESENT DURING THIS CASE AND OBSERVED THAT THE DISTAL TIP OF THE SUTURE TRIMMER WAS MISSING AFTER RETRACTION, AND INFORMED THE PHYSICIAN. THE PHYSICIAN DECIDED NOT TO INTERVENE TO REMOVE THE TIP. THE PATIENT WAS REPORTED BY THE PERCLOSE REP AS DOING WELL 15 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38105 SUTURE TRIMMER KP+T KNOT PUSHER MGB PERCLOSE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other