BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIGUIDE 4F GUIDING CATHETER

    MDR report key: 169323 · Received May 11, 1998

    Report

    Report Number
    2951420-1998-00009
    Event Type
    Other
    Date Received
    May 11, 1998
    Date of Event
    October 13, 1994
    Report Date
    November 7, 1994
    Manufacturer
    MEDTRONIC MIS
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CASE REPORT RECEIVED FROM DR. ON 11/21/1994 BY TELEFAX. OP-REPORT: 1. DIAGNOSTIC ANGIOGRAPHY OF THE AVM AND ITS FEEDING VESSELS USING - OMNI GUIDE 4F CATHETER, MIS. 2. ADVANCING OF MICRO-CATHETER INTO THE A. MENINGIA USING - OMNI SELCT-10 2F CATHETER, MIS. BOTH, WIRE AND CATHETER HAVE BEEN SHAPED IN SMALL CURVE AT TIP BY THE DR. (USING STEAM WITH MICRO-CATHETER). DR. MADE PRESSURE TEST AND FLUSHED CATHETERS WITH SALINE SOLUTION BEFORE HE ADVANCED THEM INTO PT. AND THEY WERE FLUSHED WHILE THEY WERE LYING IN VESSELS. BUT HE DIDN'T FLUSH SYSTEM WHEN HE WAS CHANGING WIRE ON MICRO CATHETER. BECAUSE HE DIDN'T USE Y-SHAPED CONNECTOR BETWEEN THE CATHETER SYSTEM AND SALINE-SOLUTION HE ALWAYS HAD TO DISCONNECT AND RECONNECT FLUSHING SYSTEM FROM CATHETER SYSTEM. SHORTLY AFTER ADVANCING OF GUIDE CATHETER CLOT OF COAGULATED BLOOD (LENGTH 1 CM) APPEARED OUT OF END OF CATHETER. PT THEN GOT 5000 UNITS OF HEPARIN. 3. EMBOLIZATION OF VESSEL WITH A - TARGET PLATINIUM COIL T-10, 5 MM, STR. FIBR. AND - TARGET COIL PUSHER- 10 (0.012"), 177 CM. 4. TESTING A. CEREBRI MEDIA AND MAKING A DECISION, WHETHER TO CONTINUE WITH THIS VESSEL OR TO APPROACH AVM AREA THROUGH VENOUS SYSTEMS. IN THIS ATTEMPT DR. USED - OMNI GUIDE 4F CATHETER, MIS AND BALT MAGIC-1.5F MICRO-CATHETER, 155 CM. DR. USED BALT-MAGIC BECAUSE HE THOUGHT OF CO'S MICRO CATHETER AS BEING TO TRAUMATIC AT TIP FOR THIS APPROACH. MAGIC SHOWED REAL GOOD PERFORMANCE - DR IS VERY EXPERIENCED USER OF THIS BRAND. APPLICATING CONTRAST MEDIA DR SAW THAT BLOOD STREAM IN VESSEL WAS SLOWED DOWN BY THROMBUS ATTACHED TO ONE SIDE OF VESSELS WALL. DR. WITHDRAW WHOLE CATHETER SYSTEM AT ONCE, REPLACED MIS GUIDE BY "STANDARD" TERUMO DIAGNOSTIC CATHETER (0.035"), INSERTED BALT MAGIC CATHETER AGAIN AND APPLICATED 200,000 UNITS OF UROKINASE TO SITE OF THROMBUS. AFTER 45 MIN HE COULDN'T SEE IMPROVEMENT IN BLOOD STREAM AND DECIDED TO END CASE AT THIS STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIGUIDE 4F GUIDING CATHETER VASCULAR GUIDING CATHETER DQO MEDTRONIC MIS GC44393 C012294

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening| O| R