BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCI RETRIEVER V 3.0 FIRM

    MDR report key: 1592720 · Received January 26, 2010

    Report

    Report Number
    2954917-2009-00028
    Event Type
    Malfunction
    Date Received
    January 26, 2010
    Date of Event
    December 28, 2009
    Report Date
    January 26, 2010
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K082034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    DURING THE PHYSICIAN'S SECOND ATTEMPT USING A MERCI RETRIEVER V 3.0 FIRM DEVICE TO RETRIEVE A RIGHT MCA OCCLUSION INCLUDING HARD PLAQUE, THE DISTAL END OF THE RETRIEVER DETACHED. THE PHYSICIAN SUCCESSFULLY REMOVED THE RETRIEVER DISTAL END FROM THE PT USING ANOTHER RETRIEVER DEVICE. THE PHYSICIAN WAS NOT ABLE TO RESTORE FLOW IN THE VESSEL. NO PT COMPLICATIONS WERE REPORTED. THE DEVICE INSTRUCTIONS FOR USE (IFU) INCLUDES A WARNING THAT PROVIDES SEVERAL RECOMMENDATIONS TO REDUCE THE RISK OF FRACTURE. ONE OF THE RECOMMENDATIONS IS TO MAINTAIN THE MICROCATHETER TIP POSITION UP TO THE HELIX LOOPS DURING MANIPULATION AND WITHDRAWAL. THE INVOLVED DEVICE SEGMENTS WERE ANALYZED. THE CORE WIRE FRACTURED OVER 1 CENTIMETER PROXIMAL FROM THE PROXIMAL HELIX LOOP. THE FRACTURE MODE WAS A COMBINATION OF TORSION AND BENDING. THIS SPECIFIC TYPE OF FRACTURE CANNOT OCCUR IF THE IFU RECOMMENDATION INDICATED ABOVE IS FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 3.0 FIRM CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90113 33570

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention