BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1822501 · Received August 26, 2010

    Report

    Report Number
    2953144-2010-01726
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 28, 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 TWO ADDITIONAL PERCLOSE PROGLIDE DEVICES INDICATED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    DEVICE ISSUE #1: SUTURE PULLED OUT OF ARTERY. 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 PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS RETRACTED TO PULL THE SUTURE TAUT, THE SUTURE WITH THE KNOT CAME OUT OF THE ARTERY. THE VESSEL WAS RE-WIRED AND THE PROGLIDE DEVICE REMOVED AND TWO ADDITIONAL PROGLIDE DEVICES WERE USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 89004-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention (PART 12673-03, LOT 89004-6H)| VESSEL CLOSURE: X2 PERCLOSE PROGLIDE