BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDEWIRE

    MDR report key: 3073152 · Received April 23, 2013

    Report

    Report Number
    9681834-2013-00046
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 15, 2013
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE INVOLVED DEVICE HAS NOT BEEN RETURNED BY THE USER FACILITY, BUT THERE IS NO INDICATION THAT A PRODUCT FAILURE OCCURRED IN RELATION TO THE REPORTED EVENT. IN ADDITION, NO FAILURE WAS IDENTIFIED DURING THE QA INVESTIGATION AT THE MANUFACTURING FACILITY INCLUDING TESTING OF A RETAINED SAMPLE FROM THE REPORTED LOT AND A SAMPLE FROM A CURRENT PRODUCTION LOT. CONCLUSIONS - BASED ON INFORMATION RECEIVED FROM THE CONTACT AT THE USER FACILITY WHO REPORTED THAT THE PHYSICIAN DECIDED TO INSERT THE PROXIMAL END OF THE GUIDEWIRE INTO THE VASCULATURE IN AN ATTEMPT TO CROSS AN OCCLUSION, AND SUBSEQUENTLY, A VESSEL PERFORATION OCCURRED. BASED ON THE EVALUATION OF A RETAINED SAMPLE FROM THE REPORTED LOT AND A SAMPLE FROM A CURRENT PRODUCTION LOT. SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE USER FACILITY MEDWATCH REPORT WAS RECEIVED FROM THE FDA. THE REPORT PROVIDED ADDITIONAL INFORMATION INCLUDING THE LOT NUMBER AND PRODUCT CODE OF THE DEVICE. THEREFORE, A RESERVE SAMPLE FROM THE REPORTED LOT WAS EVALUATED, IN ADDITION TO A SAMPLE FROM A CURRENT PRODUCTION LOT. PLEASE NOTE THAT INSERTION OF THE PROXIMAL END OF THE GUIDE WIRE INTO THE PATIENT IS NOT AN INTENDED USE OF THIS DEVICE. THEREFORE, PRODUCT PERFORMANCE TESTS FOR THAT TYPE OF IMPROPER USE HAD NOT BEEN PREVIOUSLY CONDUCTED. IN RESPONSE TO THIS REPORTED EVENT, A LIMITED EVALUATION WAS PERFORMED TO COMPARE THE FORCE CREATED BY APPLYING AXIAL PRESSURE ON THE PROXIMAL END VS. DISTAL END OF A RETAINED SAMPLE FROM THE REPORTED LOT OF GUIDE WIRES. AS EXPECTED, THE STIFFER PROXIMAL END WAS FOUND TO TRANSMIT A HIGHER FORCE THAN THE DISTAL END. IN ADDITION, A SECOND TEST CONFIRMED THAT THERE WAS NO MEASUREABLE DIFFERENCE IN THE TRANSMITTED FORCE USING A RETAINED SAMPLE FROM THE REPORTED LOT AND A SAMPLE FROM A CURRENT PRODUCTION RUN. QA INVESTIGATION USING THE RETAINED AND CURRENT PRODUCTION SAMPLES HAS CONFIRMED NO EVIDENCE OF A PRODUCT DEFECT OR MALFUNCTION. PRODUCT FILES, INCLUDING COMPLAINTS, WERE REVIEWED FOR THE LAST 3 CALENDAR YEARS PLUS (B)(4) 2013 (I.E. FROM JANUARY-2010 TO (B)(4) 2013). A REVIEW OF THESE FILES CONFIRMED THAT THIS IS THE FIRST COMMUNICATION RECEIVED BY TERUMO INDICATING THAT A VESSEL PERFORATION OR ANY OTHER EVENT HAD OCCURRED IN RELATION TO THE USER INSERTING THE PROXIMAL END OF THE GLIDEWIRE INTO A PATIENT. THIS SINGLE OCCURRENCE IS CONSIDERED TO BE AN ISOLATED EVENT DUE TO INTENTIONAL IMPROPER USE OF THE DEVICE BASED ON THE CLINICAL DISCRETION OF A LICENSED PHYSICIAN, AND IS NOT CONSIDERED INDICATIVE OF AN INCREASING TREND. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    METHOD - (NO TESTING METHODS PERFORMED). - THE INVOLVED DEVICE HAS NOT BEEN RETURNED BY THE USER FACILITY AND NEITHER THE PRODUCT CODE NOR THE LOT NUMBER ARE KNOWN. THEREFORE, THE FAILURE INVESTIGATION WAS LIMITED TO A REVIEW OF USER FACILITY INFORMATION. CONCLUSIONS - (DEVICE NOT RETURNED). (USER ERROR CAUSE OR CONTRIBUTED TO EVENT). - THE CONTACT AT THE USER FACILITY REPORTED THAT THE PHYSICIAN INSERTED THE PROXIMAL END OF THE GUIDEWIRE INTO THE VASCULATURE, AND SUBSEQUENTLY, A VESSEL PERFORATION REPORTEDLY OCCURRED. THERE IS NO EVIDENCE THAT THE REPORTED ISSUE WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. 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 WOULD INDICATE THAT THE PHYSICIAN'S TECHNIQUE IS THE MOST LIKELY CONTRIBUTING FACTOR TO THE REPORTED VESSEL PERFORATION. THE POTENTIAL FOR SUCH AN EVENT IS ADDRESSED IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE BY STATEMENTS SUCH AS THE FOLLOWING: "MANIPULATE THE GLIDEWIRE SLOWLY AND CAREFULLY IN THE VESSEL WHILE CONFIRMING THE BEHAVIOR AND LOCATION OF THE WIRE'S TIP UNDER FLUOROSCOPY."; "IF ANY RESISTANCE IS FELT, OR IF THE TIPS BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDEWIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL."; AND "THE GLIDEWIRE SHOULD BE USED BY A PHYSICIAN WHO IS WELL TRAINED IN MANIPULATION AND OBSERVATION OF GUIDE WIRES UNDER FLUOROSCOPY." 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

    THE USER FACILITY REPORTED THAT A VESSEL PERFORATION OCCURRED DURING A PROCEDURE WHILE UTILIZING A STIFF GLIDEWIRE. INFORMATION OBTAINED DURING FOLLOW-UP COMMUNICATION WITH CONTACT AT THE USER FACILITY INCLUDED: THE PHYSICIAN HAD INSERTED THE PROXIMAL END OF THE GUIDEWIRE INTO THE VASCULATURE; SUBSEQUENTLY A VESSEL PERFORATION REPORTEDLY OCCURRED; WHEN ASKED IF ANY ADDITIONAL INFORMATION WAS AVAILABLE, THE CONTACT EXPLAINED THAT NO FURTHER INFORMATION WOULD BE PROVIDED BY THE USER FACILITY; AND IT HAD NOT BE DECIDED WHETHER TO SUBMIT A USER FACILITY MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 1 FOR MFG. REPORT # 9681834-2013-00046 TO PROVIDE NEW / UPDATED INFORMATION OBTAIN FROM THE USER FACILITY MEDWATCH REPORT NUMBER (B)(4), WHICH WAS RECEIVED BY TERUMO FROM THE FDA ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175523 GLIDEWIRE GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 110906

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention