BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V 2.0 FIRM EXT PEBAX

    MDR report key: 3063653 · Received April 17, 2013

    Report

    Report Number
    0002954917-2013-00047
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    December 4, 2012
    Report Date
    March 8, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, STROKE IS NOTED AS A POTENTIAL COMPLICATION ASSOCIATED WITH SUCH PROCEDURES IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE TWO RETRIEVERS WERE USED FOR A LEFT MIDDLE CEREBRAL ARTERY OCCLUSION; TWO PASSES WERE MADE WITH ANOTHER RETRIEVER AND TWO WITH THE SUBJECT DEVICE. THE FOLLOWING DAY INCREASED HEMORRHAGIC INFORMATION WAS CONFIRMED AT THE OCCLUDED AREA. A 39MG OF TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAD ADMINISTERED INTRAVENOUSLY.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, TWO RETRIEVERS WERE USED FOR A LEFT MIDDLE CEREBRAL ARTERY OCCLUSION; TWO PASSES WERE MADE WITH ANOTHER RETRIEVER AND TWO WITH THE SUBJECT DEVICE. THE FOLLOWING DAY INCREASED HEMORRHAGIC INFORMATION WAS CONFIRMED AT THE OCCLUDED AREA. 39MG OF TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAD ADMINISTERED INTRAVENOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165145 V 2.0 FIRM EXT PEBAX CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention MERCI V 2.0 SOFT (CONCENTRIC)