BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1920337 · Received December 10, 2010

    Report

    Report Number
    2953144-2010-03193
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 17, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. (B)(4) - FAILURE TO FOLLOW STEPS. (DATE OF EVENT): THE FACILITY REPORTER INDICATED THE EVENT OCCURRED DURING THE PREVIOUS WEEK FROM THE DATE IT WAS REPORTED TO THE MANUFACTURER REPRESENTATIVE. THE DATE OF (B)(6) 2010 IS BEING USED AS THE BEST ESTIMATE DATE. (B)(4).

    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, AFTER CLIP DEPLOYMENT, DIFFICULTY WAS EXPERIENCED DURING DEVICE REMOVAL FROM THE PATIENT'S ANATOMY. THE ACCESS PORTS WERE USED; HOWEVER, THE THUMB ADVANCER WAS NOT RETRACTED AND THE DEVICE WAS PULLED OUT IN THAT CONDITION. HEMOSTASIS WAS ACHIEVED WITH THIS DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT. 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-REDWOOD CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention