BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLORADO TIP

    MDR report key: 545050 · Received February 9, 2004

    Report

    Report Number
    545050
    Event Type
    Injury
    Date Received
    February 9, 2004
    Date of Event
    September 8, 2003
    Report Date
    February 9, 2004
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A BILATERAL BREAST REDUCTION IN WHICH "ALL EXCISION WAS CARRIED OUT WITH THE COLORADO NEEDLE TIP." AT 1855PM THAT EVENING, THE PATIENT WAS NOTED TO HAVE PROGRESSIVE SWELLING AND TIGHTNESS OF THE LEFT BREAST AND WAS IMMEDIATELY TAKEN TO THE OR OPERATING ROOMFOR EVACUATION OF A LEFT BREAST HEMATOMA. EARLY THE FOLLOWING MORNING, 21 HOURS AFTER THE ORIGINAL SURGERY, THE SAME SYMPTOMS WERE NOTED IN THE RIGHT BREAST AND AGAIN PT WAS RETURNED TO THE OR FOR EVACUATION OF A HEMATOMA. A HEMATOLOGY CONSULTATION WAS REQUESTED THAT SAME DAY; THE HEMATOLOGIST'S ASSESSMENT WAS "NO CLINICAL EVIDENCE OF COAGULOPATHY." THE NEXT MO THE PATIENT WAS NOTED TO BE ANEMIC AND A TRANSFUSION WAS ADVISED BUT REFUSED BY THE PATIENT ON RELIGIOUS GROUNDS. SQ PROCRIT WAS ORDERED. THE PATIENT HAD RECURRENT SYMPTOMS IN THE RIGHT BREAST AND REQUIRED A THIRD RETURN TRIP TO THE OR, AGAIN TO EVACUATE A HEMATOMA. THE HEMATOLOGIST CONTINUED TO FOLLOW THE PATIENT, A COAGULOPATHY WORK-UP WAS DONE, AND THE PATIENT WAS PLACED ON IVINTRAVENOUS AMICAR. BECAUSE OF PTS 3 DIFFERENT BLEEDS, THE PATIENT'S HEMOGLOBIN DROPPED TO 5 AND PT WAS TRANSFERRED TO THE ICU INTENSIVE CARE UNIT FOR MONITORING. BECAUSE OF PT RELIGIOUS BELIEFS, PT INITIALLY REFUSED BLOOD TRANSFUSIONS. THEY WERE ADVISED OF THE CRITICAL NATURE OF THEIR CONDITION. DISCUSSED SITUATION WITH FAMILY AND FINALLY AGREED TO TRANSFUSION. THEY RECEIVED 3 UNITS OF BLOOD. THE HEMATOLOGIST NOTED "NO OBVIOUS COAGULOPATHY SO FAR"; WORKUP FOR VON WILLEBRAND'S DISEASE WAS STILL PENDING. THE AMICAR WAS DISCONTINUED. PT WAS DISCHARGED HOME IN GOOD CONDITION.IT WASN'T UNTIL THERE WERE TWO MORE CASES SIMILAR TO THIS ONE THAT USE OF THE COLORADO TIP WAS IDENTIFIED, THROUGH A ROOT CAUSE ANALYSIS, AS THE POSSIBLE COMMON CAUSE; THE SURGEON HAD ONLY RECENTLY BEGUN TO USE THIS PARTICULAR DEVICE FOR THIS PROCEDURE. (BOTH OF THE OTHER CASES ARE ALSO BEING REPORTED.) THE SAME SURGEON WAS INVOLVED IN ALL 3 EVENTS. IT IS UNKNOWN IF THE SURGEON WAS USING THE DEVICE DIFFERENT FROM WHAT IS RECOMMENDED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, THEY WERE UNAWARE OF THE POSSIBLE LINK BETWEEN THE 3 CASES FOR ALMOST 3 MONTHS AFTER THE LAST ONE WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLORADO TIP ESU TIP GEI MEGADYNE MEDICAL PRODUCTS, INC NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR NO OTHER THERAPIES