BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2001842 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01220
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 31, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (AGE AT TIME OF EVENT): PATIENT AGE WAS REPORTED AS MID AGED/NOT ELDERLY. (WEIGHT): PATIENT WEIGHT WAS REPORTED AS AVERAGE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE FIRST STARCLOSE SE IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE STARCLOSE SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING SHEATH SPLITTING CARVING WAS NOTED. THE DEVICE WAS REMOVED AND ANOTHER STARCLOSE SE DEVICE WAS USED WITH THE SAME RESULTS. THE PHYSICIAN INDICATED HE REMOVED THE DEVICES FROM THE PATIENT'S ANATOMY USING THE SAFETY FEATURES AND USED MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS. THERE WERE NO 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-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention