BEUDAMED
    FDA Adverse Event Death Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2001636 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01198
    Event Type
    Death
    Date Received
    February 25, 2011
    Date of Event
    January 17, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED; HOWEVER, THE INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. NOTE: THE ESTIMATED DATE OF DEATH AND THE ESTIMATED DATE OF THE EVENT, BOTH WERE REPORTED AS OCCURRING TWO WEEKS BEFORE (B)(6) 2011.

    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 UNSPECIFIED PROCEDURE. REPORTEDLY, DURING CLIP DEPLOYMENT, THE CLIP DEPLOYED INTRA-ARTERIAL, THIS WAS REMOVED SURGICALLY. AN UNSPECIFIED TIME LATER, THE PATIENT EXPIRED OF INTERNAL BLEEDING FROM AN UNSPECIFIED LOCATION. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, IT WAS DETERMINED THAT THIS IS A DUPLICATE OF MANUFACTURER REPORT NUMBER 2024168-2011-01197.

    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 Death