BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 22147148 · Received June 4, 2025

    Report

    Report Number
    3001845648-2025-00259
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    April 28, 2025
    Report Date
    July 18, 2025
    Manufacturer
    COOK IRELAND LRD
    Product Code
    FGE
    UDI-DI
    10827002217079
    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. THE DEVICE EVALUATION OF ZSO-7-10 OF C2247578 LOT NUMBER COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION, ALL THE DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ZSO-7-10 OF C2247578 LOT NUMBER DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL REVIEW: 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), "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." THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0045). IT IS KNOWN THAT DEVICE WAS NOT INSPECTED FOR DAMAGE PRIOR TO USE. IT IS ALSO KNOWN THAT A 0.025 INCH WIRE GUIDE WAS ATTEMPTED TO BE USED WITH THE DEVICE. ADDITIONALLY, FROM THE INFORMATION RECEIVED, IT IS ALSO KNOWN THAT THE 0.025 INCH WIRE GUIDE WAS ALSO USED WITH THE REPLACEMENT DEVICE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. HOWEVER, BASED ON THE AVAILABLE INFORMATION, IT APPEARS THAT THE STENT WAS ALREADY BENT BEFORE IT WAS LOADED ONTO THE WIRE GUIDE. 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 ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. BASED ON THE PATIENT/EVENT INFORMATION PROVIDED THEY USED A STRAIGHTENER TO UNFOLD THE PIGTAIL SECTION AND INSERTED THE GUIDE WIRE, BUT THE WIRE DID NOT PASS THROUGH AS THE PIGTAIL SECTION BENT AT THE TIP. HENCE THE POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE KINK OCCURRING WHILE IT WAS BEING STRAIGHTENED AS IT WAS BEING LOADED ONTO THE WIRE GUIDE. CONFIRMATION OF COMPLAINT. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED PRIOR TO USE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. BASED ON THE PATIENT/EVENT INFORMATION PROVIDED A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE KINK OCCURRING WHILE IT WAS BEING STRAIGHTENED AS IT WAS BEING LOADED ONTO THE WIREGUIDE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, NO HEALTH CONSEQUENCES OR IMPACTS WERE REPORTED. THE COMPLAINT OCCURRED DURING DEVICE PREPARATION AND DID NOT MAKE CONTACT WITH THE PATIENT. ANOTHER ZSO-7-10 DEVICE WAS USED TO COMPLETE THE PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    THE NURSE WAS PREPARING TO USE THE ZSO-7-10 AND HAD JUST OPENED THE PACKAGING OF THE NEW ZSO-7-10 WHEN SHE DISCOVERED THAT THE SIDE HOLE OF THE FIRST PIGTAIL WAS BENT. THEREFORE, THEY HAD TO USE A NEW ZSO-7-10. WAS THE FUNCTIONALITY OF THE DEVICE TESTED PRIOR TO NOTICING THE DAMAGE? YES. · IF YES, PLEASE PROVIDE ADDITIONAL DETAILS (INCLUDING OTHER DEVICES THAT MAY HAVE ENGAGED WITH THE COOK. DEVICE). THEY FLUSHED STERILE DISTILLED WATER INSIDE THE STENT, AND THERE WERE NO ISSUES WITH THE FLUSHING FUNCTION. ADDITIONALLY, THERE WERE NO ABNORMALITIES IN THE PRODUCT'S APPEARANCE. WERE ANY PREPARATORY STEPS PERFORMED TO THE DEVICE (PER INSTRUCTIONS FOR USE, IF APPLICABLE) PRIOR TO NOTICING THE DAMAGE? YES. · IF SO, PLEASE DESCRIBE HOW THE DEVICE WAS PREPARED: THEY USED A STRAIGHTENER TO UNFOLD THE PIGTAIL SECTION AND INSERTED THE GUIDE WIRE, BUT THE WIRE DID NOT PASS THROUGH AS THE PIGTAIL SECTION BENT AT THE TIP. WHAT WAS THE TARGET LOCATION FOR THE STENT? CBD. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. THE PRODUCT IS STORED IN A DRAWER INSIDE THE ERCP ROOM. WHEN THERE IS NO PROCEDURE, IT IS ALWAYS IN A DARK CONDITION WITHOUT ANY LIGHT. WAS THE DEVICE AT THE CENTER OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? NO WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE? NO. (IF YES, PLEASE DETAIL ANY OTHER DEFECTS OBSERVED.) WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THE REPLACEMENT DEVICE IN THIS PROCEDURE?* VISIGLIDE 2, 0.025 STRAIGHT. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. *WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? NO

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-JUL-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81236 ZIMMON BILIARY STENT FGE - CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LRD G21707 C2247578 10827002217079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown