BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1022115 · Received March 25, 2008

    Report

    Report Number
    2953144-2008-00196
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    March 2, 2008
    Report Date
    March 5, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SUTURE PULLED THROUGH THE TISSUE TRACT. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PHYSICIAN WAS MAINTAINING TENSION ON THE RAIL SUTURE, IT DID NOT HOLD IN PLACE AND WAS PULLED OUT OF THE TISSUE TRACT. THE KNOT COULD NOT BE COMPLETED. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THERE WAS NO ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 58138-6H

    Patients

    Seq Age Sex Outcome Treatment
    1