BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1912921 · Received December 2, 2010

    Report

    Report Number
    2953144-2010-03064
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    AV-REDWOOD CITY
    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). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. (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 RIGHT COMMON FEMORAL ARTERY AFTER A CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, THE CLIP WAS DEPLOYED AND THE DEVICE GOT STUCK IN THE PATIENT'S ANATOMY. THE PHYSICIAN USED THE ACCESS PORTS, PULLED BACK THE THUMB ADVANCER AND SLID BACK THE SAFETY RELEASE BUTTON IN AN ATTEMPT TO RETRIEVE THE DEVICE WITHOUT SUCCESS. COUNTER-TRACTION WAS APPLIED TO ULTIMATELY REMOVE THE DEVICE AND MANUAL COMPRESSION WAS APPLIED FOR 10 MINUTES TO ACHIEVE HEMOSTASIS. 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 930066H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention HEPARIN