BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1060665 · Received June 13, 2008

    Report

    Report Number
    2953144-2008-01045
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: UNKNOWN. SYMPTOMS/AE: LATE ACCESS SITE BLEEDING. TIME OF SYMPTOMS/AE: AFTER VESSEL CLOSURE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, APPROXIMATELY 3-4 HOURS AFTER THE PROCEDURE WHILE THE PATIENT WAS AMBULATING, BLEEDING OCCURRED. IT WAS NOT KNOWN IF THE BLEEDING WAS ARTERIAL OR FROM THE TISSUE TRACT. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention