BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1053277 · Received May 28, 2008

    Report

    Report Number
    2953144-2008-00950
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 2, 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, US
    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 FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THE PERCLOSE PROGLIDE DEVICE #1 PART # 12673-03, LOT # 60068-6H, INDICATED IS BEING FILED UNDER MEDWATCH MFR # 2953144-2008-00949.

    Description of Event or Problem · 1

    DEVICE # 2 MALFUNCTION: UNK. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN IN TRAINING ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY USING A PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. THE PROGLIDE DEVICE WAS DEPLOYED SUCCESSFULLY; HOWEVER, AFTER ADVANCING AND TIGHTENING UP THE KNOT, HEMOSTASIS WAS NOT ACHIEVED. A SECOND PROGLIDE WAS ATTEMPTED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A STARCLOSE DEVICE. THERE WERE NO ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO 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 60068-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT # 60068-6H| DEVICE #1 PERCLOSE PROGLIDE 12673-03