BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI BALLOON GUIDE CATHETER 8F

    MDR report key: 1971540 · Received January 24, 2011

    Report

    Report Number
    2954917-2011-00001
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 24, 2011
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    010954
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN INFLATED THE MERCI BALLOON GUIDE CATHETER (BGC) 8F IN THE PT. THE BALLOON WAS INFLATED IN THE PT FOR ABOUT 10 MINS. WHEN THE BGC WOULD NOT DEFLATE, THE PHYSICIAN PULLED THE BGC OUT OF THE PT WHILE IT WAS STILL INFLATED. THIS CAUSED A SMALL DISSECTION AT THE MID ICA. PHYSICIAN DID STATE THAT THE PT WAS "NORMAL" AFTER 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 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 8F CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL, INC. 90073 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other