BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1864503 · Received October 6, 2010

    Report

    Report Number
    2953144-2010-02425
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    July 1, 2010
    Report Date
    September 15, 2010
    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
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, SEVERAL EVENTS FOR THE LAST TWO MONTHS HAVE OCCURRED WHERE THE PHYSICIANS HAVE EXPERIENCED DIFFICULTY IN SPLITTING THE SHEATH AND DEPLOYING THE CLIP. THE DEVICES WERE REMOVED AND THE CLIP WOULD BE FOUND AT THE DISTAL END OF THE SHEATH. HEMOSTASIS IN THE EVENTS WAS ACHIEVED USING MANUAL COMPRESSION THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, 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 - VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention