BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCI BALLOON GUIDE CATHETER 8F, 95 CM

    MDR report key: 2616652 · Received June 11, 2012

    Report

    Report Number
    2954917-2012-00049
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    May 22, 2012
    Report Date
    June 1, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    010954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED ON THE RETURNED DEVICE. THE RESULTS OF THE INVESTIGATION ON THE RETURNED DEVICE SHOWED THAT THE INFLATION LUMEN WAS OCCLUDED BY A DAMAGE WRINKLED OUTER SHAFT. THE MFG RECORDS FOR 8F BALLOON GUIDE CATHETER DEVICE, LOT NUMBERS, 35196, WERE REVIEWED AND NO ANOMALIES WERE FOUND THAT ARE RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    PT WAS AN (B)(6) MALE WITH A RIGHT INTERNAL CAROTID ARTERY (ICA) OCCLUSION. PT WAS INITIALLY ADMINISTERED INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV T-PA), BUT IT WAS NOT EFFECTIVE. THEN MERCI RETRIEVER WAS USED FOR THE REMOVAL OF THE CLOT. TH PT HAD AN AORTA WITH SEVERE CURVATURE AND THE PHYSICIAN HAD A HARD TIME BRINGING UP THE MERCI BALLOON GUIDE CATHETER (BGC, 8F X 95 CM) TO THE ICA. WHEN WITHDRAWING BGC AFTER PROCEDURE, THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN WITHDREW THE BGC WITH THE BALLOON STILL INFLATED AND BURST IT AT THE INTRODUCER SHEATH INTENTIONALLY. 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, 95 CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL, INC. 90073 35196

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other