BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER

    MDR report key: 450194 · Received March 26, 2003

    Report

    Report Number
    2029214-2003-00011
    Event Type
    Death
    Date Received
    March 26, 2003
    Date of Event
    February 25, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE WAS FOR TREATMENT OF GRADE II/III BRAIN AVM IN RIGHT MCA. AFTER 10 MINUTES OF MANIPULATION TO GAIN ACCESS, THE CATHETER WAS POSITIONED NEAR THE NIDUS OF THE AVM. AFTER TWO SUPERSELECTIVE ANGIOGRAPHY RUNS WITH CONTRAST MEDIA, THE CATHETER WAS RINSED WITH SALINE, USING A 1CC SYRINGE, TO PREPARE THE CATHETER FOR GLUE (N-BCA) EMBOLIZATION. AFTER THE 2ND OR 3RD RINSE CYCLE WITH THE SALINE, THE DOCTOR FELT A NOTICEABLE DIFFERENCE IN INJECTION PRESSURE. AT THAT POINT THE BASELINE VITAL SIGNS OF THE PT DETERIORATED RAPIDLY. THE DOCTOR THEN DECIDED TO PERFORM ANOTHER SUPERSELECTIVE ANGIOGRAPHY WITH CONTRAST MEDIA THROUGH THE SAME CATHETER. THE ANGIOGRAPHY CONFIRMED THAT THE PT HAD HEMORRHAGED AT OR NEAR THE AVM, DUE TO EXTRAVAZATION OF CONTRAST EXTRAVASCULARLY. THE CATHETER WAS REMOVED, AND IT WAS NOTICED THAT THE CATHETER HAD RUPTURED 2-3" FROM THE TIP. THE DOCTOR NOTED THAT HE CONFIRMED, VIA BIPLANE FLUOROSCOPY, THAT THE CATHETER WAS NOT KINKED PRIOR TO SUPERSELECTIVE ANGIOGRAPHY. AFTER THE HEMORRHAGE, THE PT BECAME COMATOSE AND DIED FOUR DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER NEURO MICRO CATHETER KRA MICRO THERAPEUTICS, INC. 105-5065 930304J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death