BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1120784 · Received August 15, 2008

    Report

    Report Number
    2953144-2008-01326
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 24, 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. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: FAILURE TO ADVANCE THUMB ADVANCER. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A TRAINED PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED ARTERY USING THE STARCLOSE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE THUMB ADVANCER COULD NOT BE ADVANCED. THE SAFETY RELEASE BUTTON WAS DEPRESSED AND THE DEVICE WAS REMOVED. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    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 Required Intervention