BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1122749 · Received August 18, 2008

    Report

    Report Number
    2953144-2008-01330
    Event Type
    Injury
    Date Received
    August 18, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 25, 2008
    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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. DEVICE #1 PROGLIDE, PART# 12673-05, LOT # 50072-6H, IS BEING FILED UNDER MEDWATCH MFR REPORT NUMBER: 2953144-2008-01329. DEVICE #3 STARCLOSE, PART# 14677-02, LOT # UNK, IS BEING FILED UNDER A SEPARATE MFR REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: FAILURE TO DEPLOY. 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 OF A HEAVILY CALCIFIED FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED THE SUTURE WAS NOT PRESENT. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. A STARCLOSE WAS USED TO ACHIEVE HEMOSTASIS. A 10CM HEMATOMA DEVELOPED AT THE SITE TREATED WITH "DIGITAL/MANUAL PRESSURE." THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L 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 50072-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DEVICE #1 PROGLIDE