BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V 2.5 SOFT EXT

    MDR report key: 3138843 · Received May 30, 2013

    Report

    Report Number
    0002954917-2013-00084
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    July 11, 2012
    Report Date
    May 15, 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

    THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, PATIENT HEMORRHAGE IS NOTED AS 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISPOSED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE TWO RETRIEVERS WERE USED FOR A RIGHT MIDDLE CEREBRAL ARTERY OCCLUSION (RMCA). IT WAS REPORTED THAT POST PROCEDURE A SUBARACHNOID HEMORRHAGE (SAH) WAS CONFIRMED AROUND THE CEREBRAL BASE. FOR FIVE DAYS POST PROCEDURE SPINAL DRAINAGE WAS PERFORMED TO REDUCE THE INTRACRANIAL PRESSURE. THE PHYSICIAN STATED THAT THE SAH MAY HAVE BEEN CAUSED BY DAMAGE TO THE PERFORATOR VESSEL.

    Description of Event or Problem · 1

    DURING THE PROCEDURE TWO RETRIEVERS WERE USED FOR A RIGHT MIDDLE CEREBRAL ARTERY OCCLUSION (RMCA). IT WAS REPORTED THAT POST PROCEDURE A SUBARACHNOID HEMORRHAGE (SAH) WAS CONFIRMED AROUND THE CEREBRAL BASE. FOR FIVE DAYS POST PROCEDURE SPINAL DRAINAGE WAS PERFORMED TO REDUCE THE INTRACRANIAL PRESSURE. THE PHYSICIAN STATED THAT THE SAH MAY HAVE BEEN CAUSED BY DAMAGE TO THE PERFORATOR VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240031 V 2.5 SOFT EXT CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MERCI V 2.5 SOFT (CONCENTRIC)