BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 540199 · Received July 16, 2004

    Report

    Report Number
    540199
    Event Type
    Malfunction
    Date Received
    July 16, 2004
    Date of Event
    July 13, 2004
    Report Date
    July 16, 2004
    Manufacturer
    MEDTRONIC VASCULAR INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ADMINISTERED HEPARIN. WITH THE 8 FRENCH SHEATH, AND GUIDE WIRE INSTALLED. THE CATHETER WAS ADVANCED TO THE AORTA. THE GUIDE WIRE WAS PULLED BACK. AS THE PHYSICIAN STARTED TO TORQUE THE CATHETER, IT FOLDED OVER ITSELF. THERE WAS NO EVIDENCE OF THE CATHETER BEING DAMAGED PRIOR TO USE. AT THIS TIME THE PHYSICIAN RE-INSERTED THE WIRE TO THE SITE OF THE CATHETER, AND REMOVED THE CATHETER, GUIDE WIRE, AND SHEATH AT THE SAME TIME. NOTHING WAS LEFT BEHIND IN THE PATIENT. FLUOROSCOPY WAS ON DURING THE ENTIRE PROCEDURE. MANUAL PRESSURE WAS APPLIED TO THE SITE; THEN A VESSEL SEALING DEVICE WAS APPLIED. AN ACT (ACTIVATED CLOTTING TIME) WAS BEING DONE AT THIS TIME, AND THE READING WAS ROUGHLY 280. THERE WAS ANOTHER SHEATH AT THE SITE. THIS WAS A 5 FRENCH SHEATH, INSTALLED IN CASE THEY NEEDED TO PACE THE PATIENT. IT WAS NEVER USED, BUT PULLED WITH THE OTHER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC GUIDING CATHETER DYB MEDTRONIC VASCULAR INC. * 209453

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR NO OTHER THERAPIES