BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 17369829 · Received July 21, 2023

    Report

    Report Number
    3001845648-2023-00572
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 6, 2023
    Report Date
    September 22, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002221670
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA 510K#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-7-7 ZIMMON BILIARY STENT OF LOT NUMBER C2010383 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 ZSO-7-7 DEVICES ARE SUBJECTED TO VISUAL AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ZSO-7-7 OF LOT NUMBER C2010383 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 WITH LOT NUMBER C2010383. INSTRUCTIONS FOR USE /OR LABEL REVIEW: THE INSTRUCTIONS FOR USE, IFU0045 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.¿ THE INSTRUCTIONS FOR USE ALSO ALSO STATE "CARE MUST BE EXERCISED WHEN STRAIGHTENING THE PIGTAIL CURLS* IN ORDER TO AVOID KINKING OR BREAKING THE STENT". 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 CONFIRMED BASED ON CUSTOMER /OR REP TESTIMONY. SUMMARY OF INVESTIGATION: FAILURE IDENTIFIED: AS PER CUSTOMER TESTIMONY PIGTAIL SECTION BENT. CONFIRMED QUANTITY OF 1 DEVICE, REPORTED 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 CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE STENT 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-7-7 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-7-7. THEY DIDN'T CHANGE THE GUIDE WIRE. A LOT NUMBER OF NEW ZSO-7-7 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

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 22-SEP-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147980 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C2010383 10827002221670

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown