BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT SET

    MDR report key: 11342024 · Received February 18, 2021

    Report

    Report Number
    3001845648-2021-00116
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 21, 2021
    Report Date
    May 24, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    1 X ZEBD-7-7 OF LOT NUMBER UNKNOWN INVOLVED IN THIS COMPLAINT WAS UNAVAILABLE FOR RETURN TO CIRL FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS LINKED TO (B)(4) TO CAPTURE USER ERROR OCCURRED IN THIS EVENT. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE LOT NUMBER OF THE COMPLAINT STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZEBD-7-7 ARE SUBJECTED TO VISUAL AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE IN CIRL. THE JAPANESE PACKAGING INSERT (C-ESO202M16) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER.¿ IT IS TO BE NOTED THAT THIS DEVICE WAS USED SUCCESSFULLY, HOWEVER THE WIRE GUIDE USED WAS OF INCORRECT WIRE GUIDE SIZE . ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE USE OF A NON-RECOMMENDED WIRE GUIDE WITH THE DEVICE. IT MAY BE NOTED THE DEVICE LABEL INDICATES A 0.035¿ WIRE GUIDE FOR USE WITH THIS DEVICE AND ALL SIMULATED USE TESTING TO DATE HAS BEEN COMPLETED USING A 0.035¿ WIRE GUIDE. AS PER ADDITIONAL INFORMATION RECEIVED A 0.025" WIRE GUIDE WAS USED . SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 24-MAY-21. RESULTS AND CONCLUSIONS ARE IN SECTION H OF THIS REPORT.

    Description of Event or Problem · 0

    THE STENT WAS SUPPOSED TO BE USED IN THE BILE DUCT. SINCE A WIRE GUIDE (VISIGLIDE2 0.025-INCH/RPN#G-260-2545S/OLYMPUS ) DID NOT PASS THROUGH THE STENT, THE PHYSICIAN CHECKED THE DEVICE AND FOUND THAT THE PIGTAIL OF THE STENT WAS KINKED, SO HE STOPPED USING THE REPORTED STENT.((B)(4)) THEREFORE, ANOTHER ZEBD-7-7 WAS USED INSTEAD. ((B)(4))NO ADVERSE EVENTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240211 ZIMMON BILIARY STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1