BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI RETRIEVER

    MDR report key: 1598388 · Received January 28, 2010

    Report

    Report Number
    2954917-2010-00001
    Event Type
    Injury
    Date Received
    January 28, 2010
    Date of Event
    October 19, 2009
    Report Date
    January 28, 2010
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 01/19/2010, WE RECEIVED A LETTER FROM FDA'S MEDWATCH PROGRAM REGARDING A VOLUNTARY REPORT. ACCORDING TO THE REPORT, A STROKE PT BEING TREATED WITH A MERCI RETRIEVER ON (B) (6) 2009, EXPERIENCED SUBARACHNOID BLEED IN BOTH HEMISPHERES AND AROUND ENTIRE BRAINSTEM. PER PHONE CONVERSATION WITH FDA JANUARY 21, 2010, NO ADDITIONAL INFO IS AVAILABLE AS THE REPORTER REQUESTED ANONYMITY. THE REPORTER, ACCORDING THE REPORT, IS A PHYSICIAN AT A SECONDARY HOSPITAL WHO SUBSEQUENTLY MET WITH THE STROKE PT AND FAMILY. THERE WAS INSUFFICIENT INFO WITHIN THE REPORT TO PERFORM A MORE THOROUGH INVESTIGATION. VESSEL PERFORATION AND INTRACRANIAL HEMORRHAGE ARE LISTED AS POSSIBLE COMPLICATIONS IN THE RETRIEVER INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other