BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851525 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02086
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    December 16, 2008
    Report Date
    December 17, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, RESISTANCE WAS FELT DURING REMOVAL OF THE STARCLOSE SE DEVICE. IN ACCORDANCE WITH INSTRUCTIONS FOR USE A DILATOR WAS INSERTED INTO THE ACCESS PORTS RELEASING THE LOCKING MECHANISM AND THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PT ANATOMY. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THE VESSEL LOCATOR WING WAS NOTED TO BE "BROKEN/UNRAVELED" AFTER REMOVAL OF THE DEVICE. THE VESSEL LOCATOR WINGS WERE CONFIRMED TO REMAIN INTACT, NOT BROKEN OFF. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 70048-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention