BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1904500 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02943
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 28, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 TECHNICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, DURING THUMB ADVANCER DEPLOYMENT, RESISTANCE WAS FELT AND THE EXCHANGE SHEATH TUBING APPEARED TO BUNCH-UP. THE EXCHANGE SHEATH TUBING WAS STRAITENED OUT BY MANIPULATING THE ANGLE OF THE CLIP APPLIER, WHICH ENABLED EXCHANGE SHEATH SPLITTING TO BE COMPLETED. WHEN THE DEVICE WAS REMOVED, THE STARCLOSE SE CLIP WAS FOUND DEPLOYED IN THE INTENDED LOCATION AND HEMOSTASIS WAS ACHIEVED. 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 IMPLANTABLE CLIP MGB AV-REDWOOD CITY

    Patients

    Seq Age Sex Outcome Treatment
    1