BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1812234 · Received August 16, 2010

    Report

    Report Number
    2953144-2010-01656
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 22, 2010
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE ISSUE: DIFFICULT TO REMOVE. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE STARCLOSE SE WAS DIFFICULT TO REMOVE FROM THE ANATOMY. THE DILATOR WAS INSERTED INTO THE ACCESS PORTS, RELEASING THE LOCKING MECHANISM ON THE THUMB ADVANCER, RESULTING IN THE LOCATOR WINGS FULLY COLLAPSING AND THE STARCLOSE SE DEVICE WAS REMOVED FROM THE PT'S ANATOMY. HEMOSTASIS WAS ACHIEVED WITH THE STARCLOSE SE CLIP. 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 SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1