BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCENTRIC RETRIEVER X6

    MDR report key: 502624 · Received November 21, 2003

    Report

    Report Number
    2954917-2003-00005
    Event Type
    Malfunction
    Date Received
    November 21, 2003
    Date of Event
    October 24, 2003
    Report Date
    November 21, 2003
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THROMBUS WAS VERY DIFFICULT TO CROSS WITH A GUIDEWIRE SUGGESTING A HARD IMPACTED CLOT. THE CLOT EXTENDED FROM BELOW THE OPHTHALMIC ARTERY TO THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE FIRST RETRIEVER X6 WAS NOT SUCCESSFUL AT RETRIEVING CLOT. THE DEVICE DID NOT FRACTURE BUT IT WAS DISTORTED. A SECOND RETRIEVER X6 (RETRIEVER #2) WAS USED. AFTER CROSSING THE CLOT IT WAS TORQUED (TURNED) FIVE TURNS COUNTER-CLOCKWISE. IT STRETCHED AND HE RELEASED THE TENSION. MD THEN APPLIED FIVE TURNS CLOCKWISE. THE DEVICE AND HE RELEASED THE TENSION. HE REPEATED THE CLOCKWISE TORQUE/RELEASE CYCLE 4 OR 5 TIMES (A TOTAL OF 20 TO 25 ROTATIONS) THEN PULLED. THE DEVICE FRACTURED AND WAS STUCK IN THE CLOT AT THE MCA/ICA TURN. HE TRIED TO RETRIEVE THE FRACTURED HELIX WITH A THIRD X6 RETRIEVER (RETRIEVER #3). IT ENGAGED THE FAILED RETRIEVER VERY WELL AND HE REPEATED NUMEROUS CYCLES OF APPLYING TENSION AND RELAXING BUT THE FAILED RETRIEVER DID NOT MOVE. THE DEVICE EVENTUALLY STRETCHED BUT IT WAS REMOVED FROM THE PATIENT INTACT. A FOURTH RETRIEVER (A RETRIEVER X5) WAS ALSO USED TO ATTEMPT TO RETRIEVE THE FAILED RETRIEVER BUT WITH NO SUCCESS. HE NEXT MOVED ONTO A 2MM SNARE AND WAS ABLE TO REMOVE THE FRACTURED RETRIEVER. PER PHYSICIAN, THE PATIENT CONDITION WAS NOT MADE WORSE BY DEVICE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCENTRIC RETRIEVER X6 PERCUTANEOUS FOREIGN BODY RETRIEVER DQY CONCENTRIC MEDICAL, INC. 90037 31513

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention