BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAC 057, 115CM

    MDR report key: 2141194 · Received June 22, 2011

    Report

    Report Number
    2954917-2011-00012
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 22, 2011
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K090335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN HAD DIFFICULTY PASSING THE MARKSMAN MICROCATHETER (MANUFACTURED BY EV 3) ACROSS A SECTION OF THE INTERNAL CAROTID ARTERY (ICA) WHERE THERE WAS A LARGE ANEURYSM. PHYSICIAN HAD THE NEURON 053 (MANUFACTURED BY PENUMBRA) IN THE HORIZONTAL ICA. WHEN THE NEURON 053 WOULD NOT TRACK DISTALLY INTO THE ANEURYSM, HE SWITCHED OUT FOR A MERCI DAC 057, 115CM. THE DAC 057 TRACKED NICELY UP TO AND INTO THE ANEURYSM, BUT ON ITS APPROACH, IT CAUGHT ON THE VESSEL JUST PROXIMAL TO THE ANEURYSM. WHILE PUSHING THE DAC THROUGH, A SMALL TEAR OCCURRED IN THE ICA. HE REPAIRED THE TEAR USING A BALLOON AND THEN CONTINUED THE PROCEDURE. THE PATIENT DID NOT SEEM ADVERSELY AFFECTED FOLLOWING THE PROCEDURE. THERE WAS NO EVIDENCE OF CONCENTRIC MEDICAL DEVICE MALFUNCTION AND THE DEVICE INSTRUCTIONS FOR USE LISTS RELATED POSSIBLE COMPLICATIONS. ALSO, WHILE THE CONCENTRIC MEDICAL DEVICE USE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT OUTCOME, THERE ARE OTHER FACTORS INDEPENDENT OF THE SUBJECT DEVICE (E.G., PATIENT FACTORS, DEVICE USE FACTORS, OTHER DEVICES EMPLOYED, DRUGS ADMINISTERED, ETC.) THAT ALSO MAY HAVE CAUSED OR CONTRIBUTED TO THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAC 057, 115CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL, INC. 90130 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention