BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONCENTRIC RETRIEVER L5

    MDR report key: 810832 · Received January 29, 2007

    Report

    Report Number
    MW1041789
    Event Type
    Other
    Date Received
    January 29, 2007
    Date of Event
    January 28, 2007
    Report Date
    January 29, 2007
    Manufacturer
    CONCENTRIC MEDICAL, INC
    Product Code
    NRY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PT CAME TO HOSP WITH A STROKE CONFIRMED BY CT SCAN, BECAUSE SHE COULD NOT RECEIVE TPA, THE RADIOLOGIST WAS ASKED TO PERFORM A CEREBRAL ANGIOGRAM AND MECHANICAL CLOT RETRIEVIAL USING THE MERCI DEVICE. THE CLOT WAS LOCATED INTRACRANIALLY ON THE RIGHT. DURING THE FIRST PASS, USING A L5 RETREIVER; THE DEVICE BECAME IMBEDDED IN THE CLOT. THE RADIOLOGIST BELIEVES THAT THE CLOT WAS ALREADY SO HARD THAT THE DEVICE COULD NOT FUNCTION PROPERLY. NOT KNOWING THIS AT THE TIME, HE PREFORMED THE NORMAL RETREIVAL PROCESS. THIS CAUSED THE END OF THE L5 DEVICE TO BREAK OFF WITHIN THE CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCENTRIC RETRIEVER L5 L5 RETRIEVER NRY CONCENTRIC MEDICAL, INC RATRIEVER L5 32629

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other