BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE TRIMMER KP+T

    MDR report key: 496231 · Received November 14, 2003

    Report

    Report Number
    2953144-2003-00252
    Event Type
    Injury
    Date Received
    November 14, 2003
    Date of Event
    September 27, 2003
    Report Date
    October 21, 2003
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE WITH THE PERCLOSE AT (THE CLOSER AK) FOLLOWING AN INTERVENTIONAL PROCEDURE. FLUOROSCOPY CONFIRMED THE ACCESS SITE TO BE IN THE COMMON FEMORAL ARTERY. THE PERCLOSE A-T WAS SUCCESSFULLY DEPLOYED AND THE SUTURE RETRIEVED FOR KNOT DELIVERY. THE SUTURE WAS LOADED ONTO THE SNARED KNOT POSITIONER. WHEN ATTEMPTING TO TIGHTEN THE KNOT DOWN, THE SNARED KNOT POSITIONER BECAME ATTACHED TO THE ARTERIAL WALL. IT WAS REPORTED THAT THE PHYSICIAN TURNED THE DEVICE 180 DEGREES IN AN ATTEMPT TO RELEASE IT FROM THE ARTERY. HE THEN PULLED BACK ON THE DEVICE AND A SMALL SECTION OF ARTERIAL TISSUE THAT WAS CAUGHT IN THE KNOT POSITIONER TORE AWAY FROM THE ARTERY. THE ARTERIAL TISSUE AND SUTURE WERE VISIBLE IN THE TIP OF THE KNOT POSITIONER UPON DEVICE REMOVAL. HEMOSTASIS HAD NOT BEEN ACHIEVED AND MANUAL COMPRESSION WAS HELD ON THE ARTERIOTOMY. THE PT WAS TRANSFERRED TO SURGERY FOR ARTERIAL REPAIR WHICH INCLUDED GRAFT PLACEMENT. THERE WAS NO REPORT OF ADVERSE PT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE TRIMMER KP+T SUTURE MEDIATED CLOSURE MGB PERCLOSE, INC. NA 06086-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R HEPARIN