BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1872838 · Received October 14, 2010

    Report

    Report Number
    2953144-2010-02495
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DEPLOYMENT OF THE FOOT AND THE NEEDLE, SUTURE RETRIEVAL WAS COMPLETED; HOWEVER, WHEN THE LEVER WAS RETURNED TO ITS ORIGINAL POSITION, THE FOOT FAILED TO PARK. THE PHYSICIAN REMOVED THE DEVICE WITH THE FOOT OPENED AND TISSUE OR CALCIUM WAS FOUND ON THE FOOT PREVENTING THE FOOT FROM BEING RETRACTED. NO ARTERIAL DAMAGE WAS REPORTED. NO CALCIFICATION OR SCAR TISSUE WAS REPORTED. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. 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 - VASCULAR SOLUTIONS NA 91039-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention