BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851466 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02137
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    February 18, 2009
    Report Date
    March 19, 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
    MI, US
    Reporter Occupation
    OTHER

    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 FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE TRAINED IN THE USE OF 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 USED TO FACILITATE DEVICE REMOVAL. HEMOSTASIS WAS ACHIEVED WITH THE DEVICE. THERE WERE NO ADVERSE PT EFFECTS REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 71040-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention