BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS INTRODUCER II H

    MDR report key: 3417845 · Received October 18, 2013

    Report

    Report Number
    9681834-2013-00134
    Event Type
    Injury
    Date Received
    October 18, 2013
    Date of Event
    November 13, 2009
    Report Date
    November 13, 2009
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SECTION WAS COMPLETED BY THE MANUFACTURER PER CFR 803.52(F) (11) BECAUSE THE INFORMATION WAS NOT INITIALLY COMPLETED BY THE USER FACILITY (B)(4). CONCLUSIONS, ARE BASED ON THE EVALUATION OF INFORMATION PROVIDED BY THE USER FACILITY; IS BASED ON THE EVALUATION OF A SAMPLE FROM A CURRENT PRODUCTION LOT. THE REFERENCED GUIDEWIRE DEVICE WAS NOT RETURNED FOR EVALUATION AND NEITHER THE SPECIFIC PRODUCT CODE OR LOT NUMBER IS KNOWN. THEREFORE, THE FAILURE INVESTIGATION WAS LIMITED TO ASSESSMENT OF INFORMATION PROVIDED BY THE USER FACILITY AND EVALUATION OF A SAMPLE FROM A CURRENT PRODUCTION RUN. INSPECTION AND TESTING OF THE SAMPLE FOUND NO DEFECTS OR ANOMALIES AND CONFIRMED THAT PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. THIS MANUFACTURER MEDWATCH REPORT IS BEING SUBMITTED BECAUSE THE RADIFOCUS INTRODUCER II H WAS IDENTIFIED AS BEING INVOLVED IN AN EVENT WHERE THE DEVICE WAS REPORTEDLY PUSHED THROUGH THE VESSEL WALL. BASED UPON THE ASSESSMENT OF THE PHYSICIAN, THERE IS NO EVIDENCE THAT INDICATES THIS EVENT WAS RELATED TO A DEFECT OR MALFUNCTION OF THE GUIDE WIRE. ALTHOUGH THE CAUSE FOR THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION, THE DESCRIPTION OF THE EVENT PROVIDED BY THE CONTACT AT THE USER FACILITY, AND THE ASSESSMENT OF THE PHYSICIAN, THE PHYSICIAN'S TECHNIQUE DURING THE PROCEDURE IS THE MOST LIKELY CONTRIBUTING FACTOR TO THE REPORTED EVENT. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE BY STATEMENTS INCLUDING: "ADVANCE OR WITHDRAW THE MINI GUIDE WIRE SLOWLY. IF RESISTANCE IS MET, DO NOT ADVANCE OR WITHDRAW THE MINI GUIDE WIRE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED BASED ON INFORMATION THAT WAS OBTAINED FROM AN ARTICLE PRESENTED DURING THE 22ND ANNUAL MEETING OF THE JAPANESE ASSOCIATION OF CARDIOVASCULAR INTERVENTION AND THERAPIES. THE ARTICLE STATED THAT A PERFORATION OF THE ARTERY OCCURRED DURING INSERTION OF THE RADIFOCUS INTRODUCER II H INTO THE FEMORAL ARTERY. ADDITIONAL INFORMATION OBTAINED FROM FOLLOW-UP COMMUNICATIONS WITH THE USER FACILITY CONFIRMED: THE PROCEDURE BEING PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION; WHEN THE MINI GUIDEWIRE WAS INSERTED INTO THE FEMORAL ARTERY UNDER THE BLIND OPERATION, THE WIRE PERFORATED THROUGH A SUPERFICIAL CIRCUMFLEX ILIAC ARTERY; THE PHYSICIAN PERFORMED EMBOLIZATION USING HEMOSTAT TO STOP THE BLEEDING; THE PATIENT WAS REPORTED TO BE "STABLE" FOLLOWING THE PROCEDURE; AND THE PHYSICIAN STATED, "IF J SHAPE GUIDEWIRE WAS USED, THE INCIDENT MIGHT NOT HAVE OCCUR, HOWEVER, THIS INCIDENT WAS NOT CAUSED BY THE PRODUCT. WE NEED MORE CAREFUL OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535104 RADIFOCUS INTRODUCER II H CATHETER INTRODUCER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention HEMOSTAT (GELFORM)