BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1181174 · Received September 30, 2008

    Report

    Report Number
    2953144-2008-01588
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    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, BUT THREE UNUSED STERILE STARCLOSE SE DEVICE WITH THE SAME LOT NUMBER, IS EXPECTED TO BE RETURNED FOR EVALUATION. THEY HAVE NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: UNSPECIFIED. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: NONE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AN UNSPECIFIED FAILURE OCCURRED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 65046-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention