BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIGUIDE 7FC

    MDR report key: 163973 · Received March 12, 1998

    Report

    Report Number
    2951420-1998-00003
    Event Type
    Other
    Date Received
    March 12, 1998
    Date of Event
    February 24, 1998
    Report Date
    March 12, 1998
    Manufacturer
    MEDTRONIC MIS
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT PRIOR TO INTRODUCING THE OMNIGUIDE 7FC GUIDING CATHETER INTO THE PT'S VERTEBRAL ARTERY USING AXILLARY ARTERY ACCESS, THE CURVE AT THE TIP OF THE GUIDING CATHETER WAS RESHAPED USING STEAM-SHAPING. THE OMNIGUIDE WENT THROUGH A CORDIS 7F INTRODUCER SHEATH TO ENTER THE AXILLARY ARTERY AND WAS TRACKED OVER A 0.035" TERUMO GUIDEWIRE TO THE ENTRANCE OF THE VERTEBRAL ARTERY. AFTER WAITING TO PREPARE THE MICROCATHETER AND MICROGUIDEWIRE, BUT BEFORE PUTTING THE MICROCATHETER INTO THE OMNIGUIDE, THE PHYSICIAN DISCOVERED THAT THE RADIOPAQUE MARKER BAND, LOCATED AT THE TIP OF THE CATHETER, HAD DETACHED AND DEPOSITED INTO A MUSCULAR BRANCH OF THE PT'S VERTEBRAL ARTERY. NO CLINICAL SEQUELAE FOR THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIGUIDE 7FC OMNIGUIDE GUIDING CATHETER DYB MEDTRONIC MIS GC74778-60 GC25109

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other