BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE GUIDEWIRE

    MDR report key: 6519980 · Received April 25, 2017

    Report

    Report Number
    9681834-2017-00082
    Event Type
    Injury
    Date Received
    April 25, 2017
    Date of Event
    March 29, 2017
    Report Date
    April 25, 2017
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K091417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - THE UDI NUMBER FOR THIS PRODUCT CODE IS NOT REQUIRED TO BE REGISTERED. E1 - ESTABLISHMENT NAME: TOKYO WOMEN'S MEDICAL UNIVERSITY YACHIYO MEDICAL CENTER, DUE TO CHARACTER LIMITATIONS THE ENTIRE NAME OF THE FACILITY WOULD NOT FIT IN THE DESIGNATED SECTION. THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL AND MAGNIFYING INSPECTION FOUND NO ANOMALIES. THE DISTAL EXTREMITY WAS FOUND TO HAVE BEEN ROUND-PROCESSED WITHOUT FAIL. THE OUTSIDE DIAMETER WAS CONFIRMED TO MEET MANUFACTURING SPECIFICATION. THE MOBILITY PERFORMANCE ON THE SEGMENT AT THE DISTAL END WHERE THE HYDROPHILIC COATING WAS APPLIED, WAS DETERMINED AND CONFIRMED TO MEET MANUFACTURING SPECIFICATION. LUBRICITY WAS CONFIRMED TO MEET MANUFACTURING SPECIFICATION. SUBSEQUENTLY, MOBILITY RESISTANCE TEST WAS PERFORMED AND CONFIRMED TO MEET MANUFACTURING SPECIFICATION. PUSHING RESISTANCE WAS DETERMINED AND OBTAINED VALUE WERE VERIFIED TO MEET MANUFACTURING SPECIFICATION. THE ACTUAL LOT NUMBER WAS NOT KNOWN, POTENTIAL LOT NUMBERS WERE TRACED BACK TO BE 170116, 170119, 170120 OR 170123. A REVIEW OF MANUFACTURING AND SHIPPING INSPECTION RECORDS OF THE POTENTIALLY INVOLVED PRODUCT/LOT NUMBER COMBINATIONS CONFIRMED THAT THERE WAS NO INDICATION OF PRODUCTION-RELATED PROBLEMS. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER REPORT WITH THE POTENTIALLY INVOLVED PRODUCT CODE/LOT NUMBER COMBINATIONS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE ACTUAL DEVICE WAS CONFIRMED TO BE NORMAL PRODUCT. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTION FOR USE (IFU) WITH STATEMENTS SUCH AS THE FOLLOWING: "DO NOT FORCE THE DISTAL END OF THE INSERTION PORTION AGAINST BODY CAVITY TISSUE. THIS COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, HEMORRHAGES OR MUCOUS MEMBRANE DAMAGE." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A BILE DUCT WAS PERFORATED DURING A PROCEDURE WITH THE USE OF A GUIDEWIRE DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: REPLACEMENT OF THE ENBD TUBE PREVIOUSLY PLACED IN THE RIGHT INTRAHEPATIC BILE DUCT WITH A NEW ENBD TUBE WAS THE INTENDED PROCEDURE; CANNULATION WAS PERFORMED FROM THE LATERAL SIDE OF THE ENBD TUBE EXISTING IN THE PATIENT; THE ACTUAL SAMPLE WAS INSERTED INTO THE MIDDLE SEGMENT OF THE BILE DUCT AND THE EXISTING ENBD TUBE WAS WITHDRAWN; SUBSEQUENTLY, THE ACTUAL SAMPLE WAS ADVANCED INTO THE DEEPER SEGMENT IN ORDER TO CROSS THE STENOSED SEGMENT; ON THE FLUOROSCOPIC IMAGE THE ACTUAL SAMPLE WAS ADVANCED IN THE DIRECTION OF THE RIGHT INTRAHEPATIC BILE DUCT; CROSSING OF THE STENOSED SEGMENT WAS SUCCESSFUL; WITH FARTHER ADVANCEMENT OF THE ACTUAL SAMPLE SOME RESISTANCE WAS NOTED; THINKING THE ACTUAL SAMPLE HAD GOTTEN CAUGHT IN THE STENOSED SEGMENT, THE SURGEON INJECTED CONTRAST MEDIA AT THAT SITE; INSTEAD OF THE IMAGE OF THE BILE DUCT, AN ABNORMAL IMAGE WAS OBTAINED; AND THE BILE DUCT WAS FOUND TO HAVE BEEN PERFORATED WITH A LEAK OF CONTRAST MEDIA INTO THE ABDOMINAL CAVITY.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NUMBER 1 TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY. THE INITIAL REPORTED ADVERSE EVENT OF A BILE DUCT PERFORATION WAS DETERMINED TO BE INCORRECT. BASED ON ADDITIONAL INFORMATION RECEIVED, THERE WAS NO OCCURRENCE OF PERFORATION AND THE PATIENT WAS NOT HARMED. THEREFORE, THIS REPORT DOES NOT MEET THE CRITERIA FOR ADVERSE EVENT REPORTING. HOWEVER, BECAUSE THE INITIAL REPORT HAS ALREADY BEEN SUBMITTED PRIOR TO THE ADDITIONAL INFORMATION BEING RECEIVED, THIS REPORT IS BEING SUBMITTED AS FOLLOW UP TO FURTHER DETAIL THE INVESTIGATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300901 SINGLE USE GUIDEWIRE GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other