BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1844679 · Received September 23, 2010

    Report

    Report Number
    2953144-2010-02040
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 31, 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
    OH, 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 IS FORTHCOMING. ADDITIONALLY, EIGHT UNOPENED STERILE STARCLOSE SE DEVICES, FROM THE SAME LOT NUMBER, ARE EXPECTED TO BE RETURNED FOR EVAL. A F/U REPORT WILL BE SUBMITTED WITH ANY ADD'L RELEVANT INFO.

    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 THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, DURING THUMB ADVANCER DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED AND EXCHANGED SHEATH SPLITTING COULD NOT BE COMPLETED. IT WAS NOT SPECIFIED HOW THE DEVICE WAS REMOVED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADD'L INFO 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 87026-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention