BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851414 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02173
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    June 1, 2009
    Report Date
    June 2, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED THE STARCLOSE SE DEVICE USED IN THE CLOSURE PROCEDURE WAS DISCARDED; HOWEVER, THE LOT NUMBER WAS PROVIDED. FIVE STERILE REP SAMPLES WITH THE SAME PART NUMBER AS THE COMPLAINT DEVICE AND TWO SEPARATE LOT NUMBERS (73060-6H AND 69063-6H) WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED ON ALL OF THE RETURNED DEVICES AND THE DEVICES PASSED WITH ACCEPTABLE RESULTS. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A ROOT CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLES. 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 TRAINED IN THE USE OF THE STARCLOSE SE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PT'S ARTERY. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED, AND THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PT ANATOMY. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADDITIONAL 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 73060-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention