BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1022556 · Received March 31, 2008

    Report

    Report Number
    2953144-2008-00224
    Event Type
    Injury
    Date Received
    March 31, 2008
    Report Date
    March 6, 2008
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: LEG ISCHEMIA. TIME OF SYMPTOMS/AE: TWO DAYS POST PROCEDURE. IT WAS REPORTED THAT TWO DAYS POST SUCCESSFUL ARTERIOTOMY CLOSURE THE PT RETURNED TO THE HOSP AND WAS DIAGNOSED WITH ISCHEMIA OF THE LEG. THE STARCLOSE CLIP WAS SURGICALLY REMOVED AND THE WOUND CLOSED. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization