BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI MICROCATHETER 18L

    MDR report key: 1292028 · Received January 16, 2009

    Report

    Report Number
    2954917-2008-00024
    Event Type
    Injury
    Date Received
    January 16, 2009
    Date of Event
    July 28, 2008
    Report Date
    January 14, 2009
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQO
    PMA / PMN Number
    K003086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NONE OF THE REPORTED INFORMATION SUGGESTED THAT ANY CONCENTRIC MEDICAL DEVICE MALFUNCTIONED. THE CURRENT DEVICE INSTRUCTIONS FOR USE (IFU) LISTS VESSEL DISSECTION AND PERFORATION AS POSSIBLE PROCEDURAL COMPLICATIONS. ALSO, THERE IS A WARNING IN THE IFU THAT PROVIDES RECOMMENDATIONS TO PREVENT VESSEL DAMAGE. BECAUSE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    A CONCENTRIC EMPLOYEE FIRST BECAME AWARE OF THIS EVENT IN LATE 2008 WHEN REVIEWING MERCI REGISTRY PROCEDURE NOTES RECORDED BY THE SITE. THE SITE PERSONNEL WERE NOT ABLE TO FIND RECORDS OF THE SPECIFIC MERCI RETRIEVER DEVICE(S) INVOLVED WITH THIS INCIDENT. BASED ON THE RECORDS OF DEVICES SHIPPED TO THE SITE, IT IS POSSIBLE THAT THE RETRIEVER DEVICE WAS AN L4, L5, L6, V 2.5 FIRM OR V 2.5 SOFT. COMPLETE REVASCULARIZATION WAS ACHIEVED ON THE SECOND RETRIEVAL ATTEMPT USING THE MERCI RETRIEVAL SYSTEM, EXTRACTING A LARGE AMOUNT OF CLOT. A SMALL INTIMAL FLAP WAS ELEVATED IN THE CERVICAL RIGHT ICA AS PART OF THIS PROCESS. THIS WAS EFFECTIVELY REDUCED ALONG WITH AN ACCOMPANYING STENOSIS USED BALLOON ANGIOPLASTY TECHNIQUE. FINAL CONTROL ANGIOGRAMS DEMONSTRATED COMPLETE RESTORATION OF FLOW THROUGH THE RIGHT ANTERIOR CIRCULATION WITH VIGOROUS RUNOFF THROUGH THE RIGHT MIDDLE CEREBRAL ARTERY TERRITORY AND ADDITIONAL RUNOFF TO THE RIGHT ANTERIOR CEREBRAL ARTERY TERRITORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI MICROCATHETER 18L CATHETER, INTRAVASCULAR DIAGNOSTIC DQO CONCENTRIC MEDICAL, INC. 90044 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention