BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1081338 · Received July 24, 2008

    Report

    Report Number
    2953144-2008-01236
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 3, 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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT BEEN REC'D.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: MARKER LUMEN BLOCKED. 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 THE FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, DURING THE PREPARATION PROCESS, THE DEVICE WAS FLUSHED WITHOUT DIFFICULTY; HOWEVER, AFTER THE DEVICE WAS INSERTED INTO THE ARTERY, THERE WAS NO BLEEDING FROM THE MARKER LUMEN. THE DEVICE WAS REMOVED AND COULD NOT BE FLUSHED. HEMOSTASIS WAS ACHIEVED USING A SECOND PROGLIDE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. 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 64234-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention