BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLOW HPC MICRO CATHETER

    MDR report key: 514824 · Received March 8, 2004

    Report

    Report Number
    2029214-2004-00013
    Event Type
    Injury
    Date Received
    March 8, 2004
    Date of Event
    February 12, 2004
    Report Date
    March 8, 2004
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EMBOLIZATION OF FRONTAL AVM FED OFF DISTAL M2 OF THE MCA, LEFT OR RIGHT SIDE NOT STATED, DURING EMBOLIZATION OF THIRD OF THREE PEDICLES WITH GLUE. ANGIO RUN WAS FOLLOWED BY SALINE FLUSH OF CATHETER FOLLOWED BY GLUE INJECTION. PHYSICIAN STATED THAT PT EXPERIENCED STROKE FOLLOWING EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC MICRO CATHETER MICRO CATHETER KRA MICRO THERAPEUTICS, INC. 105-5066 414525

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R