BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1822434 · Received August 26, 2010

    Report

    Report Number
    2953144-2010-01732
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 2, 2010
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SECOND PERCLOSE PROGLIDE INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    DEVICE # 1 ISSUE: SUTURE BREAK. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, THE SUTURE BROKE. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED PT ADVERSE EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    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 89039-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VESSEL CLOSURE: PERCLOSE PROGLIDE (PART 12673-03,| LOT 89039-6H)