BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851528 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02081
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. AFTER CLIP DEPLOYMENT, AN ATTEMPT WAS MADE TO REMOVE THE STARCLOSE SE DEVICE FROM THE PT ANATOMY; HOWEVER, WAS UNSUCCESSFUL. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE A DILATOR WAS INSERTED INTO THE ACCESS PORTS AND THE DEVICE WAS REMOVED SUCCESSFULLY. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 69016-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention