BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851542 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02094
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 21, 2008
    Report Date
    August 21, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, HEMOSTASIS WAS ACHIEVED WITH THE CLIP; HOWEVER, DURING REMOVAL, THE DEVICE BECAME STUCK IN THE PT'S ARTERY. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE DEVICE WAS REMOVED BY RELEASING THE LOCKING MECHANISM ON THE THUMB ADVANCER VIA THE ACCESS PORTS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L 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 66057-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention