BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2834108 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07207
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 25, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED DATE OF OCCURRENCE, EVENT REPORTEDLY OCCURRED IN (B)(6) 2012. IT IS INDICATED THAT THE DEVICE REMAINS IN THE PATIENTS ANATOMY AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY WAS ACHIEVED USING A STARCLOSE SE DEVICE AFTER A CARDIAC CATHETERIZATION PROCEDURE. REPORTEDLY, AFTER THE PROCEDURE THE PATIENT COMPLAINED OF SYMPTOMS OF ITCHINESS, PULMONARY CONGESTION, RIGHT GROIN TENDERNESS, PATIENT STATES THAT THE RIGHT GROIN IS SWOLLEN, NO SWELLING WAS VISIBLE UPON EXAMINATION. THE PATIENT ALSO HAS PAIN RADIATING DOWN THE RIGHT THIGH AND UP INTO THE RIGHT LOWER QUADRANT OF THE ABDOMEN. THE PATIENT HAS INCREASED ANXIETY. THE PATIENT REPORTED THAT ALL OF THESE SYMPTOMS STARTED AFTER THE CARDIAC CATHETERIZATION AND USE OF THE STARCLOSE SE CLOSURE DEVICE. IT IS UNKNOWN IF THE PHYSICIAN IS TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. 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-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other