BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1083435 · Received July 29, 2008

    Report

    Report Number
    2953144-2008-01250
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 7, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: MARKER LUMEN BLOCKAGE. 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 PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED ARTERY AFER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THERE WAS NO BLEEDING FROM THE MARKER LUMEN AS THE DEVICE WAS ADVANCED INTO THE ARTERY. THE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED WITH A SECOND PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L 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 62056-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention