BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER II KIT

    MDR report key: 3935273 · Received July 15, 2014

    Report

    Report Number
    1118880-2014-00023
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 30, 2013
    Report Date
    July 15, 2014
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K954234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - IS BASED ON EVALUATION OF USER FACILITY INFORMATION AND THE RETURNED SAMPLE; RESERVE SAMPLE EVALUATION. CONCLUSIONS - IS BASED UPON RESERVE SAMPLE TESTING. THE INVOLVED DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT FOUND THE SHEATH WAS RETURNED WITH THE DIAGNOSTIC CATHETER ADVANCED THROUGH IT. THE SHEATH WAS KINKED AND SHOWED EVIDENCE OF HAVING BEEN TORQUED. THE SHEATH WAS TWISTED ALONG THE LENGTH. THE DIAGNOSTIC CATHETER WAS STUCK AND UNABLE TO BE REMOVED FOR EVALUATION. AN EVALUATION OF THE REPORTED LOT AND THE SURROUNDING LOTS MANUFACTURED WAS CONDUCTED. A VISUAL EXAMINATION OF THE DEVICES REVEALED NO VISUAL DEFECTS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. THERE IS NO INDICATION THAT THERE WAS ANY RELATION TO A PRE-EXISTING DEVICE DEFECT. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION AND THE RETURNED SAMPLE PROVIDED BY THE USER FACILITY IT IS LIKELY THAT THE SHEATH MAY HAVE COME INTO CONTACT WITH SCAR TISSUE OR CALCIFICATION, CAUSING IT TO KINK. ALL CURRENTLY AVAILABLE INFORMATION HAS BEEN PLACED ON FILE BY QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A SHEATH KINK DURING A PROCEDURE. FOLLOW-UP COMMUNICATION FROM THE USER FACILITY REPORTED: PATIENT WAS PREPPED AND DRAPED; A 6-FRENCH SHEATH WAS PLACED IN THE RIGHT COMMON FEMORAL ARTERY; SELECTIVE CORONARY ANGIOGRAPHY WAS PERFORMED WITH A 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 THE PHYSICIAN WAS 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 SHEATH WERE PULLED OUT AS A 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 AND PULSATILE COULD 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 THE COILING OF THE GUIDE AND THE SHEATH UNDER FLUOROSCOPIC GUIDANCE; THE PROCEDURE WAS COMPLETED; AND THE PATIENT IS REPORTED DOING "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414294 RADIFOCUS INTRODUCER II KIT INTRODUCER CATHETER DYB TERUMO MEDICAL CORPORATION NA QD06

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR EBU 3.5 GUIDE| JR4 DIAGNOSTIC CATHETER