BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 20396954 · Received October 8, 2024

    Report

    Report Number
    3001845648-2024-00594
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 11, 2024
    Report Date
    July 3, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002221618
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: 1 UNIT OF ZSO-7-4 OF LOT NUMBER: C2141466 DEVICE WAS RETURNED FOR EVALUATION OPENED NOT IN ITS ORIGINAL PACKAGING. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ZSO-7-4 ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ZSO-7-4 OF LOT NUMBER: C2141466 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: A REVIEW OF THE MANUFACTURING RECORDS FOR THE ZSO-7-4 DEVICE CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER: C2141466. INSTRUCTIONS FOR USE/LABEL: AS PER THE INSTRUCTIONS FOR USE¿S NOTES SECTION (IFU0045), WHICH ACCOMPANIES THIS DEVICE, INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE: "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". AS PER THE PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU0045), WHICH ACCOMPANIES THIS DEVICE, "REFER TO PACKAGE LABEL FOR MINIMUM CHANNEL SIZE REQUIRED FOR THIS DEVICE." AND "WIRE GUIDE DIAMETER AND INNER LUMEN OF WIRE-GUIDED DEVICE MUST BE COMPATIBLE." THE PRODUCT LABEL STATES THE GUIDE WIRE SIZE FOR USE WITH THIS DEVICE IS 0.035". THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU/LABEL. IT IS ALSO KNOWN FROM THE AVAILABLE INFORMATION THAT THE INCORRECT WIREGUIDE WAS USED WITH THE REPLACEMENT ZSO-7-4 DEVICE TO COMPLETE THE PROCEDURE. AS PER MANAGEMENT OF COMPLAINTS PROCEDURE WHERE INFORMATION IS REVIEWED AND CATEGORIZED AS USE RELATED/OFF LABEL USE AND WHERE NO ADVERSE EVENT IS IDENTIFIED THEN NO COMPLAINT IS REQUIRED. THE EVENT IS DOCUMENTED IN THE PMS TRACKER AND REVIEWED AS PART OF POST MARKET SURVEILLANCE IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USE ERROR WAS ESTABLISHED. FROM THE INFORMATION AVAILABLE, IT IS KNOWN THAT AN INCORRECT SIZE WIRE GUIDE WAS USED WITH THE DEVICE. THE PRODUCT LABELLING INSTRUCTS THE USER TO USE A 0.035¿ WIRE GUIDE. ALL DESIGN TESTING HAS BEEN COMPLETED USING A 0.035¿ WIRE GUIDE. THEREFORE, USING AN ALTERNATIVE SIZE OF WIRE GUIDE HAS NOT BEEN TESTED AND MAY RESULT IN DAMAGE TO THE STENT. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/OR LABEL. CORRECTIVE ACTION/CORRECTION: CAPA: PR387756 ADDRESSES ANY NECESSARY CORRECTIVE ACTIONS AS A RESULT OF THIS FAILURE MODE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CONFIRMED QTY OF DEVICES: 01 DEVICE USED. (PRIOR TO PATIENT CONTACT) INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO USE ERROR - AN INCORRECT SIZE WIRE GUIDE USED WITH THE DEVICE. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    AS REPORTED: IN THE PROCESS OF LOADING THE ZSO-7-4 ONTO THE GUIDE WIRE (0.025" VISIGLIDE, STRAIGHT), THE PIGTAIL PART OF THE STENT WAS BENT. THE NURSE USED THE INCLUDED STRAIGHTENER TO STRAIGHTEN THE PIGTAIL AND TRIED TO PASS THE WIRE, BUT THE WIRE COULD NOT PASS THROUGH THE SECOND PIGTAIL SECTION. THEY USED THE NEW ZSO-7-4 TO COMPLETE THE PROCESS, AND THE GUIDE WIRE WAS NOT REPLACED. PATIENT/EVENT INFO - NOTES: FOR ALL COMPLAINTS ASK: 1. WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? 0.025" VISIGLIDE, STRAIGHT 2. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? THEY USED THE NEW ZSO-7-4 TO COMPLETE THE PROCESS.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 3 JUL 2025 AND RECEIPT OF ADDITIONAL INFORMATION ON 29 SEP 2024 AND 18 OCT 2024. DOES THE COMPLAINT RELATE TO DEVICE REPLACEMENT, DEVICE REMOVAL OR WAS IT AN OBSERVATION MADE PRIOR TO PATIENT CONTACT? ANS. OBSERVATION PRIOR TO PATIENT CONTACT, DURING PREPARATION. 2. WHAT WAS THE TARGET LOCATION FOR THE STENT? ANS. CBD. 3. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. ANS. IT IS STORED IN AN ACRYLIC CHEST OF DRAWERS INSIDE THE ERCP ROOM, AND THE LIGHTS ARE ALWAYS TURNED OFF WHEN THE PROCEDURE IS NOT TAKING PLACE. 4. WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? ANS. 0.025¿ VISI2, STRAIGHT. 5. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? ANS. YES. 6. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? ANS. YES, NORMAL. 7. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? ANS. YES. 8. WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? ANS. YES. 9. IF YES PLEASE INDICATE THE TYPE OF PROCEDURE PERFORMED. ANS. EST-STONE REMOVAL. 10. DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? ANS. NO. 11. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? ANS. A NEW ZSO-7-4 WAS USED. 12. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? ANS. NO. 13. WHAT INTERVENTION (IF ANY) WAS REQUIRED? ANS. N/A. 14. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? ANS. SAME PROCEDURE. 15. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE)? ANS. NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685342 ZIMMON BILIARY STENT FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK IRELAND LTD G22161 C2141466 10827002221618

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown