BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1800531 · Received August 12, 2010

    Report

    Report Number
    2953144-2010-01589
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE ISSUE: DIFFICULT TO REMOVE. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN UNSPECIFIED IF TRAINED IN THE USE OF THE STARCLOSE SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF MILDLY CALCIFIED FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, IT WAS NOT POSSIBLE TO REMOVE THE STARCLOSE SE DEVICE OUT OF THE PATIENT'S BODY. THE DEVICE WAS SURGICALLY REMOVED. HEMOSTASIS WAS ACHIEVED WITH SURGICAL CLOSURE. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. THE OPERATOR INADVERTENTLY FORGOT HOW TO USE THE ACCESS PORTS TO RETRACT THE THUMB ADVANCER AND CLIP DELIVERY TUBESET TO AIDE IN REMOVAL OF THE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION 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 89005-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention