BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1190243 · Received October 6, 2008

    Report

    Report Number
    2953144-2008-01631
    Event Type
    Injury
    Date Received
    October 6, 2008
    Report Date
    September 16, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION. DEVICE #2 - PROGLIDE (PART# 12673-05; LOT# 65078-6H) IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SUTURE RETRIEVAL (DEVICE #1). 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 THE COMMON FEMORAL ARTERY AFTER AN UNKNOWN PROCEDURE. REPORTEDLY, WHEN PULLING THE PLUNGER BACK TO DISENGAGE THE NEEDLES, THE KNOT AND SUTURES WERE PULLED COMPLETELY OUT OF THE ARTERY. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE WAS ATTEMPTED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING ANOTHER PROGLIDE. 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 65078-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VESSEL CLOSURE: DEVICE #2 - PROGLIDE| (PART# 12673-05, LOT# 65078-6H)