BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851496 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02103
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    January 16, 2009
    Report Date
    January 23, 2009
    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
    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

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINED USED THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE SUCCESSFULLY USED TO REMOVE THE DEVICE FROM THE PATIENT ANATOMY. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO PATIENT EFFECTS REPORTED. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention