BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 14915395 · Received July 5, 2022

    Report

    Report Number
    3001845648-2022-00400
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    May 30, 2022
    Report Date
    November 29, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 X ZSO-7-4 DEVICE OF LOT UNKNOWN INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: AS THE LOT NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ZSO-7-4 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. HISTORICAL DATA NOT REVIEWED AS LOT NUMBER UNKNOWN. TO ENSURE CONFORMITY OF ALL BATCH RELEASE PRODUCTS, PACK QC PROCEDURES, VERIFY THAT "...THE FOLLOWING INFORMATION ON THE LABEL (PRODUCT LABEL, TAG, TEMPORARY) IS CORRECT AS PER THE WORK ORDER: VERIFY THE PRESENCE OF ALL REQUIRED LABELS ON THE BACK OF THE WORK ORDER/REJECT SHEET WHERE REQUIRED". LABELLING QC PROCEDURES AS PER THIS DOCUMENT ALSO VERIFY "THE IFU SHOULD BE PLACED ON THE TYVEK SIDE OF THE POUCH UNLESS OTHERWISE INSTRUCTED IN THE PACKAGING INSTRUCTIONS". THE PRODUCT LABEL ALSO STATES THE RECOMMENDED GUIDE WIRE SIZE (0.035"). IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0045) STATES THE FOLLOWING: SELECT THE COOK STENT INTRODUCER SYSTEM (IF NOT INCLUDED) IN THE APPROPRIATE FRENCH SIZE. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USER ERROR CAN BE ATTRIBUTED TO THE USE OF A NON-RECOMMENDED WIRE GUIDE WITH THE DEVICE. IT MAY BE NOTED THE DEVICE LABEL INDICATES A 0.035¿ WIRE GUIDE FOR USE WITH THIS DEVICE AND ALL SIMULATED USE TESTING TO DATE HAS BEEN COMPLETED USING A 0.035¿ WIRE GUIDE. AS PER INFORMATION STATED A 0.025" WIRE GUIDE WAS USED. SUMMARY: FAILURE IDENTIFIED: INCORRECT SIZE WIRE GUIDE USED WITH COMPLAINT DEVICE. CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE OF USER ERROR. IT MAY BE NOTED THE DEVICE LABEL INDICATES A 0.035¿ WIRE GUIDE FOR USE WITH THIS DEVICE AND ALL SIMULATED USE TESTING TO DATE HAS BEEN COMPLETED USING A 0.035¿ WIRE GUIDE. COMPLAINT CONFIRMED BASED ON CUSTOMER TESTIMONY. 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-7-4 IN THE CBD. SO THE NURSE PREPARED THE ZSO-7-4, BUT THE PIGTAIL SECTION OF ZSO-7-4 WAS BENT AS SHE MOVED THE STENT SLEEVE (STRAIGHTNER) TO THE PIGTAIL SECTION. SHE TRIED TO PASS THE GUIDE WIRE (VISI2, 025, ANGLE TYPE) INTO THE ZSO-7-4, IT WAS IMPOSSIBLE. USER ERROR: INCORRECT WIRE GUIDE SIZE USED. SO THEY USED THE NEW ONE. THEY DID NOT CHANGE THE WIRE GUIDE. VISI2 REMAINED. USER ERROR: INCORRECT WIRE GUIDE SIZE USED WITH REPLACEMENT ZSO-7-4. 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

    SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 29-NOV-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398054 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown