BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI BALLOON GUIDE CATHETER, 8F X 95CM

    MDR report key: 1647360 · Received March 29, 2010

    Report

    Report Number
    2954917-2010-00004
    Event Type
    Injury
    Date Received
    March 29, 2010
    Date of Event
    February 17, 2010
    Report Date
    March 29, 2010
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    010954
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A MECHANICAL EMBOLECTOMY PROCEDURE TO REMOVE AN OCCLUSION IN THE LEFT MIDDLE CEREBRAL ARTERY. THE PATIENT HAD VERY TORTUOUS ARTERIES. DURING WITHDRAWAL OF THE RETRIEVER, THE 8F BALLOON GUIDE CATHETER MOVED DISTALLY. A SIGNIFICANT FLOW LIMITING DISSECTION IN THE PATIENT'S LEFT INTERNAL CAROTID ARTERY WAS NOTED AFTER A FOLLOW UP ANGIOGRAM. THIS DISSECTION WAS ATTRIBUTED TO THE DISTAL MOVEMENT OF THE BGC. A SELF EXPANDING STENT WAS DEPLOYED TO TREAT THE DISSECTION. A FOLLOW-UP ANGIOGRAM AFTER STENT DEPLOYMENT DEMONSTRATED NO SIGNIFICANT RESIDUAL FLOW LIMITING DISSECTION. AFTER STENT PLACEMENT, THE EMBOLECTOMY PROCEDURE WAS CONTINUED WITH OTHER DEVICES AND THE LEFT MIDDLE CEREBRAL ARTERY WAS FULLY RECANALIZED. THE PATIENT TOLERATED THE PROCEDURE WELL. NO IMMEDIATE POST-PROCEDURE COMPLICATIONS WERE REPORTED. THERE WAS NO EVIDENCE OF ANY DEVICE MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI BALLOON GUIDE CATHETER, 8F X 95CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL, INC. 90073 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention