BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER

    MDR report key: 3912408 · Received May 28, 2014

    Report

    Report Number
    3912408
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    June 30, 2013
    Report Date
    February 4, 2014
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS PREPPED AND DRAPED. A 6-FRENCH SHEATH WAS PLACED IN THE RIGHT COMMON FEMORAL ARTERY. SELECTIVE CORONARY ANGIOGRAPHY WAS PERFORMED WITH JR4 DIAGNOSTIC CATHETER AND AN EBU 3.5 GUIDE. AS INITIAL PICTURES WERE BEING TAKEN WITH THE EBU 3.5 GUIDE, THE SHEATH IN THE RIGHT GROIN KINKED AND TWISTED AND PHYSICIAN UNABLE TO INJECT CONTRAST. THIS WAS AN ST ELEVATION MYOCARDIAL INFARCTION AND IT WAS DECIDED TO PROCEED WITH A SECOND ARTERIAL ACCESS TO FINISH THE PROCEDURE. A 6-FRENCH SHEATH WAS PLACED IN THE LEFT COMMON FEMORAL ARTERY AND THE PROCEDURE COMPLETED.ATTENTION WAS TURNED TO THE RIGHT COMMON FEMORAL SHEATH IN THE GROIN; THE GUIDE WAS TWISTED ALONG WITH THE SHEATH IN MULTIPLE LOCATIONS. WHILE HOLDING MANUAL PRESSURE, THE SHEATH WAS SLOWLY UNCOILED AND THE GUIDE AND THE SHEATH WERE PULLED OUT AS WHOLE UNIT. WHEN THE CLEAR PORTION OF THE GUIDE WAS VISIBLE, THE GUIDE WAS CUT AND A SUPRACORE WIRE WAS PLACED THROUGH THE GUIDE. THERE WAS NO THROMBUS NOTED IN THE GUIDE. THERE WAS PULSATILE FLOW THROUGH THE GUIDE. AFTER THE WIRE PLACEMENT, THE GUIDE WAS COMPLETELY REMOVED AND A LONG SHEATH WAS PLACED TO FURTHER ASSESS THE ARTERIOTOMY SITE. A COMMON FEMORAL ANGIOGRAM SHOWED A SEVERE TORTUOSITY OF THE EXTERNAL ILIAC ARTERY, WHICH MOST LIKELY RELATED TO COILING OF THE GUIDE AND THE SHEATH UNDER FLUOROSCOPIC GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314506 RADIFOCUS INTRODUCER INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION * QD06

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR NO.