BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1380761 · Received May 12, 2009

    Report

    Report Number
    2953144-2009-00540
    Event Type
    Injury
    Date Received
    May 12, 2009
    Date of Event
    April 17, 2009
    Report Date
    April 20, 2009
    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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER ERROR (PT SELECTION) - DEVICE #2: PROGLIDE, LOT # UNK, INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #1 CUFF MISS. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND DEVICE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PT 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEVICE #2: PROGLIDE