BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI BALLOON GUIDE CATHETER 9F

    MDR report key: 2362039 · Received November 29, 2011

    Report

    Report Number
    2954917-2011-00024
    Event Type
    Injury
    Date Received
    November 29, 2011
    Date of Event
    November 21, 2011
    Report Date
    November 29, 2011
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    010954
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS A (B)(6) FEMALE WITH A LEFT MI SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). PHYSICIAN MADE ONE PASS WITH THE MERCI V 2.5 FIRM RETRIEVER, DAC 057 X 125 CM AND 9F X 80 CM BALLOON CATHETER (BGC) (ALL THREE DEVICES MANUFACTURED BY CONCENTRIC MEDICAL INC.). PHYSICIAN REMOVED TWO LARGE CHUNKS OF THE CLOT. DURING ANGIOGRAM, THE MCA WAS WIDE OPEN TO TICI-2B FLOW, BUT THERE WAS A DISSECTION IN THE CERVICAL INTERNAL CAROTID ARTERY (ICA) NEAR THE DISTAL TIP OF THE 9F X 80 CM BCG. AFTER A REPEAT ANGIOGRAM, PHYSICIAN FELT THAT IT WAS NOT FLOW LIMITING AND HE OPTED NOT TO STENT OR TREAT THE DISSECTION. HE THOUGHT THE 9F X 80 CM BCG MAY HAVE CAUSED THE DISSECTION, BUT NOT DUE TO A DEVICE FAILURE. 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 PT OUTCOME, THERE ARE OTHER FACTORS INDEPENDENT OF THE SUBJECT DEVICE (E.G., PT 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 MERCI BALLOON GUIDE CATHETER 9F CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL, INC. 90077 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other