BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2001214 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01166
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 3, 2011
    Report Date
    February 1, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (AGE AT TIME OF EVENT): REPORTED AS ABOVE 15 YEARS OLD. (WEIGHT): REPORTED AS (B)(6). (ESTIMATED DATE OF EVENT): THE REPORTER INDICATED THE EVENT OCCURRED BETWEEN DEC 2010 AND THE FIRST WEEK OF (B)(6) 2011. 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 AN UNSPECIFIED OPERATOR, THEREFORE UNKNOWN IF TRAINED IN THE USE OF THE STARCLOSE SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY (CFA) AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE CLIP WOULD NOT FIRE AFTER DEPRESSING THE DEPLOYMENT BUTTON. THE ACCESS PORTS WERE USED TO REMOVE THE DEVICE FROM THE PATIENTS GROIN, HOWEVER, THE THUMB ADVANCER WAS NOT RETRACTED. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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