BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCI RETRIEVER L6

    MDR report key: 1033190 · Received April 23, 2008

    Report

    Report Number
    2954917-2008-00005
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 23, 2008
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K071172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INSTRUCTIONS FOR USE (IFU) INCLUDES A WARNING THAT PROVIDES RECOMMENDATION TO REDUCE THE RISK OF FRACTURE. THE RESULTS OF THE INVESTIGATION ON THE RETURNED DEVICE SHOWED THAT THE CORE WIRE FRACTURED IN THE SECOND HELIX LOOP FROM THE PROXIMAL END OF THE HELIX. THERE WAS LOCALIZED BENDING OF THE WIRE ADJACENT TO THE FRACTURE SITE. BASED ON THE RESULTS OF THE INVESTIGATION, (B) (4) PHOTOS AND THE INFO PROVIDED BY THE SITE, THE MOST LIKELY CAUSE OF THE FRACTURES APPEARS TO BE A COMBINATION OF KINKING (BENDING) AND TORSION. THE MFG RECORDS FOR RETRIEVER L6 DEVICE WAS REVIEWED AND NO ANOMALIES WERE FOUND THAT ARE RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THE MERCI RETRIEVER L6 CORE WIRE FRACTURED IN THE MCA WHEN THE PHYSICIAN MADE HIS FIRST CLOT RETRIEVAL ATTEMPT. THE ENTIRE DEVICE WAS REMOVED FROM THE PT WITHOUT ANY DEVICE FRAGMENTS LEFT BEHIND. THE PLATINUM COIL DID NOT BREAK; IT CONNECTED THE DISTAL PORTION OF THE DEVICE TO THE PROXIMAL CORE WIRE. THE PT WAS NOT HARMED BY THE CORE WIRE FRACTURE. THE VESSEL WAS PARTIALLY OPENED WITH THE RETRIEVER L6 AND WAS FULLY OPENED USING LYTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER L6 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL, INC. 90060 30797

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR