BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIGUIDE 8FC GUIDING CATHETER

    MDR report key: 122380 · Received September 24, 1997

    Report

    Report Number
    2951420-1997-00010
    Event Type
    Other
    Date Received
    September 24, 1997
    Date of Event
    August 5, 1997
    Report Date
    August 27, 1997
    Manufacturer
    MEDTRONIC MICRO INTERVENTIONAL SYSTEMS
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A STENT PLACEMENT IN AN OCCLUDED RIGHT INTERNAL CAROTID ARTERY, THE PHYSICIAN ENCOUNTERED A PROBLEM WHILE USING THE OMNIGUIDE 8FC GUIDING CATHETER (PRODUCT #GC 84778, LOT # C122096-GC24969) WHICH RESULTED IN LEAVING A RADIOPAQUE MARKER BAND IN THE PT'S VASCULATURE. WHILE TRYING TO PASS THE CATHETER THROUGH THE COMMON CAROTID ARTERY TOWARDS THE RIGHT INTERNAL CAROTID ARTERY, THE RADIOPAQUE MARKER BAND DISCONNECTED FROM THE CATHETER AND WAS DEPOSITED IN A SIDE BRANCH OF THE RIGHT EXTERNAL CAROTID ARTERY. AT THE TIME THAT THE MARKER BAND CAME OFF, THE OMNIGUIDE WAS POSITIONED AT THE RIGHT EXTERNAL CAROTID ARTERY AND A MEDITECH 0.035" -260CM AMPLATZ SUPER STIFF GUIDEWIRE (6CM SUPPLE TIP) WAS IN PLACE. SINCE THE MARKER BAND COULD HAVE ENTERED THE RIGHT INTERNAL CAROTID ARTERY AND CAUSED A SERIOUS PROBLEM, THE PHYSICIAN WOULD LIKE TO KNOW IF THE EVENT WAS A RESULT OF HIS WRONG MANIPULATION OR IS THIS PROBLEM KNOWN TO OCCUR FOR THIS PRODUCT. IN THE PHYSICIAN'S PERSONAL EXPERIENCE USING 150 UNITS OF THIS PRODUCT, THIS WAS THE FIRST ENCOUNTER WITH THE MARKER BANK COMING OFF. NOTE THE EVALUATION SUMMARY ASKED FOR IN BLOCK H3 IS PROVIDED IN THE MFR'S NARRATIVE OF BLOCK H10

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIGUIDE 8FC GUIDING CATHETER VASCULAR GUIDING CATHETER DYB MEDTRONIC MICRO INTERVENTIONAL SYSTEMS 8FC C122096-GC24969

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other STENT (UNK VENDOR)| MEDITECH 0.035"-260CM AMPLATZ SUPER STIFF| GUIDEWIRE (6 CM SUPPLE TIP)