BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 17369504 · Received July 21, 2023

    Report

    Report Number
    3001845648-2023-00567
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 15, 2023
    Report Date
    January 18, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002221632
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K851962. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE 1 X ZSO-7-5 ZIMMON BILIARY STENT OF LOT NUMBER C1973913 WAS INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. HISTORICAL DATA REVIEW: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE /OR LABEL REVIEW: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0045) STATES THE FOLLOWING: ¿CARE MUST BE EXERCISED WHEN STRAIGHTENING THE PIGTAIL CURLS* IN ORDER TO AVOID KINKING OR BREAKING THE STENT¿ IT ALSO SAYS, ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS¿. ¿IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE DEVICE KINKING WHILE BEING STRAIGHTENED BY THE PIGTAIL STRAIGHTENER. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY OF INVESTIGATION: FAILURE IDENTIFIED: AS PER CUSTOMER TESTIMONY PIGTAIL WAS BENT. CONFIRMED QUANTITY OF 1 DEVICE, PRIOR TO USE. INVESTIGATION FINDINGS CONCLUDE A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE DEVICE KINKING WHILE BEING STRAIGHTENED BY THE PIGTAIL STRAIGHTENER. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER/OR REP TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE DOCTOR WANTED TO INSERT THE ZSO-7-5 IN THE CBD. THE NURSE PREPARED THE PLASTIC STENT. USING A STENT STRAIGHTENER, THE NURSE UNFOLDED THE PIGTAIL OF THE STENT, THEN PUSHED THE GUIDE WIRE (JAG WIRE 0.035" STRAIGHT) INTO THE STENT. BUT THE WIRE DID NOT ADVANCE. SHE TRIED SEVERAL TIMES BUT FAILED, AND WHEN SHE CHECKED THE STENT, THE HOLE OF PIGTAIL SECTION WAS BENT. SO THEY USED THE NEW ZSO-7-5. THEY DIDN'T CHANGE THE GUIDE WIRE. A LOT NUMBER OF NEW ZSO-7-5 WAS NOT CONFIRMED. DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT BODY? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE(S)? NO. WERE THERE ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE ADVERSE EFFECT(S)? NO.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-JAN-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586159 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C1973913 10827002221632

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown