BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F BGC 95CM

    MDR report key: 3053399 · Received April 11, 2013

    Report

    Report Number
    0002954917-2013-00043
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    July 4, 2012
    Report Date
    April 3, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K102657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. VESSEL DISSECTION AND HEMORRHAGE ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A THROMBOEMBOLISM IN THE LEFT MIDDLE CEREBRAL ARTERY M1 THAT WAS TREATED WITH THROMBOLYSIS AND ANGIOPLASTY. POST PROCEDURE A LEFT INTERNAL CAROTID ARTERY DISSECTION WAS CONFIRMED AND A CAROTID STENT WAS PLACED TO TREAT THE DISSECTION. THE PHYSICIAN STATED THAT THE CAUSE OF THE DISSECTION WAS THE STRESS ON THE VESSEL WALL CREATING BY THE BALLOON GUIDE CATHETER USED TO PERFORM THE ANGIOPLASTY. POST PROCEDURE THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA SCORE OF 3 AFTER TREATMENT. THE NEXT DAY POST PROCEDURE, A SLIGHT SUBARACHNOID HEMORRHAGE WAS CONFIRMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156612 8F BGC 95CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention MERCI RETRIEVER ( CONCENTRIC)