BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT SET

    MDR report key: 10545599 · Received September 17, 2020

    Report

    Report Number
    3001845648-2020-00616
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    June 24, 2020
    Report Date
    March 10, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002213934
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IMDRF ANNEX G CODE: G07001 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. DEVICE EVALUATION: 1 X ZEBD-7-4 OF LOT NUMBER C1726698 WAS UNAVAILABLE FOR RETURN TO CIRL FOR EVALUATION. THIS FILE CAPTURES THE OFF-LABEL USE OF THE PLACED ZEBD-7-4 BILIARY STENT FOR THE PANCREATIC CYST. THE LOT NUMBER OF THE DEVICE WAS ALSO CONFIRMED THIS FILE IS RELATED TO MDR REF #3001845648-2020-00451 WHICH WAS CREATED FOR THE KINKING OF THE INITIAL ZEBD-7-4 STENT TO BE PLACED. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION ALL ZEBD-7-4 DEVICES 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. A REVIEW OF THE MANUFACTURING RECORDS FOR ZEBD-7-4 OF LOT NUMBER C1726698 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INSTRUCTIONS FOR USE, IFU0045-7 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.¿ IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE (IFU0045-7) "THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ WHERE THE USE OF THE DEVICE FOR A CYST IN THE PANCREATIC DUCT IN THIS PROCEDURE IS NOT A STATED USE AS PER THE IFU AND THEREFORE HAS NOT BEING TESTED IN A CLINICAL SETTING. IT CAN BE NOTED THAT THE JAPANESE PACKAGING INSERT (C-ES0202M16) 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. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE ITS STATED INTENDED USE, IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. IT WAS ALSO NOTED THAT AN INCORRECT WIREGUIDE WAS USED WITH THE DEVICE. 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.

    Description of Event or Problem · 0

    DATE MANUFACTURER INFORMED WAS AMENDED ON THE 10-MAR-2021. THE INVESTIGATION WAS CONCLUDED ON THE 26-MAR-2021, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO AMEND THE DATE MANUFACTURER INFORMED IN SECTION G AND INCLUDE THE INVESTIGATION CONCLUSIONS IN SECTION H.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WHEN ADVANCING THE PIG-TAIL PART OVER A WIRE GUIDE PLACED IN THE PATIENT'S BODY, THE STENT GOT KINKED THOUGH IT WAS USED AS USUAL. THEREFORE, ANOTHER ZEBD-7-4 THAT WAS A SPARE OF THE REPORTED DEVICE WAS USED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010615 ZIMMON BILIARY STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C1726698 10827002213934

    Patients

    Seq Age Sex Outcome Treatment
    1