BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1000908 · Received February 20, 2008

    Report

    Report Number
    2953144-2008-00085
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 29, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE PULLED OUT OF TISSUE TRACK. SYMPTOMS/AE: SURGICAL INTERVENTION TO REPAIR ARTERY. TIME OF MALFUNCTION AND AE: DURING VESSEL CLOSURE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHILE RETRACTING THE DEVICE TO POSITION THE FOOT AGAINST THE ARTERIAL WALL, ONE FOOT CAME OUT OF THE ARTERY INTO THE TISSUE TRACK WHILE THE OTHER FOOT REMAINED INSIDE THE ARTERY. WHEN THE DEVICE WAS RETRACTED PLAQUE WAS FOUND TO BE ATTACHED TO THE SUTURE. THE PT WAS SENT TO THE OR ALTHOUGH HEMOSTASIS WAS ACHIEVED (BY AN UNK METHOD) PRIOR TO TRANSPORTING THE PT TO A CUT DOWN PROCEDURE THAT WAS PERFORMED BECAUSE OF THE PLAQUE. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention