BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1061463 · Received April 8, 2008

    Report

    Report Number
    2953144-2008-00236
    Event Type
    Malfunction
    Date Received
    April 8, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 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
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION WAS NOT COMPLETE. THE PERCLOSE PROGLIDE #2, PART #12673-05, LOT # 59017-6H, IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #1 CUFF MISS. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE AFTER A CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PHYSICIAN PULLED THE NEEDLE PLUNGER OUT, NO SUTURE WAS PRESENT. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS ATTEMPTED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 59017-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR DEVICE #2: PERCLOSE PROGLIDE: 13673-03| HEPARIN| LOT #59017-6H