BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 7776088 · Received August 13, 2018

    Report

    Report Number
    3001845648-2018-00383
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 13, 2018
    Report Date
    August 13, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    00827002216372
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K851962. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). LAB EVALUATION: 1 X ZSO-10-10 DEVICE OF LOT # C1408649 WAS RETURNED TO CIRL FOR EVALUATION. THE DEVICE WAS RETURNED WITH A GUIDING CATHETER AND A POSITIONING SLEEVE ON THE STENT. A LAB EVALUATION WAS HELD ON 30TH JULY 2018. DURING THE LAB EVALUATION, IT WAS NOTED THAT THE STENT WAS RETURNED WITH A POSITIONING SLEEVE/ FLAP PROTECTOR ON IT INDICATING THAT THE POSITIONING SLEEVE/ FLAP PROTECTOR (WHICH IS SUPPLIED WITH FLAP CONTAINING STENTS AND NOT DOUBLE PIGTAIL STENTS) WAS INCORRECTLY USED TO STRAIGHTEN THE PIGTAIL. ZSO-10-10 STENTS ARE NOT SUPPLIED WITH A PIGTAIL STRAIGHTENER. WHEN THE CUSTOMER WAS QUERIED REGARDING THE USE OF A POSITIONING SLEEVE/ FLAP PROTECTOR TO STRAIGHTEN THE STENT THE CUSTOMER STATED THAT "THEY BELIEVE THE SLEEVE WAS SMALL ENOUGH" HOWEVER AS THE SLEEVE IS NOT FLARED ON ONE SIDE IT SHOULD NOT BE USED TO STRAIGHTEN PIGTAILS. IT WAS ALSO NOTED THAT THE DEVICE WAS SENT BACK WITH A GUIDING CATHETER, HOWEVER DOUBLE PIGTAIL STENTS ARE INCOMPATIBLE WITH GUIDING CATHETERS THEREFORE THE USER COULD NOT ADVANCE THE STENT DUE TO USER ERROR. IT WAS ALSO NOTED THAT THERE WERE SIGNIFICANT INDENTATIONS AT THE 3RD, 4TH AND 5TH SIDEPORT HOLES ON THE DUODENAL END OF THE STENT AND MINOR INDENTATIONS AT THE 3RD, 4TH AND 5TH PORTHOLES ON THE DUCTAL END, AND THERE WAS RESISTANCE FELT WHEN PASSING A 35 THOU WIREGUIDE THROUGH THE STENT, HOWEVER THE WIREGUIDE PASSED THROUGH SUCCESSFULLY. IT IS LIKELY THAT THE KINK INDENTATIONS NOTED ON THE DEVICE WERE CAUSED WITHER WHILE TRYING TO STRAIGHTEN THE STENT USING THE FLAP PROTECTOR(FROM ANOTHER DEVICE) OR WHILE TRYING TO LOAD ONTO THE INCOMPATIBLE GUIDING CATHETER, THE INDENTATION DAMAGE THEN PREVENTED THE STENT BEING LOADED ONTO THE GUIDEWIRE. DOCUMENTS REVIEW: AS THIS EVENT WAS LIKELY ATTRIBUTED TO USER ERROR AND DEVICE MALFUNCTION DID NOT CONTRIBUTE TO THE EVENT A REVIEW OF THE MANUFACTURING RECORDS FOR THE ZSO-10-10 DEVICE OF LOT # C1408649 WAS NOT REQUIRED. IFU REVIEW: IT SHOULD BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE. FOR PIGTAIL STENTS THE USER IS INSTRUCTED TO ¿2. INTRODUCE STENT, TAPERED TIP FIRST, AND PIGTAIL STRAIGHTENER ONTO PRE-POSITIONED WIRE GUIDE UNTIL STRAIGHTENER REACHES SECOND CURL. 3. ADVANCE PUSHING CATHETER OVER WIREGUIDE TO ADVANCE PIGTAIL STENT INTO ACCESSORY CHANNEL.¿ HOWEVER IT SHOULD BE NOTED THAT 10 FR STENTS ARE NOT SOLD WITH A PIGTAIL STRAIGHTENER AND CAN BE DIRECTLY ADVANCED OVER THE WIREGUIDE. ROOT CAUSE: A ROOT CAUSE FOR THE CUSTOMER COMPLAINT CAN MOST LIKELY BE ATTRIBUTED TO USER ERROR AS THE USER ATTEMPTED TO ADVANCE THE STENT OVER A GUIDING CATHETER WHICH IS INCOMPATIBLE, THE USER THEN CORRECTLY ATTEMPTED TO ADVANCE THE STENT OVER A WIREGUIDE HOWEVER THE STENT WAS LIKELY DAMAGED (KINK INDENTATIONS OBSERVED DURING EVALUATION) DURING THE FIRST INCORRECT ATTEMPTED PASS AND THEREFORE THE USER EXPERIENCED ADVANCEMENT DIFFICULTY OVER THE WIREGUIDE. IT SHOULD BE NOTED THAT THE STENT LUMEN WAS FOUND TO BE CORRECT DURING THE LAB EVALUATION. IT SHOULD ALSO BE NOTED THAT THE KINK INDENTATIONS ON THE STENT MAY ALSO HAVE BEEN ATTRIBUTED TO THE USER ATTEMPTING TO STRAIGHTEN THE PIGTAILS USING A FLAP PROTECTOR FROM ANOTHER DEVICE AS A FLAP PROTECTOR WAS RETURNED ON THE STENT. THIS DEVICE IS NOT COMPATIBLE WITH A FLAP PROTECTOR OR A PIGTAIL STRAIGHTENER OR GUIDING CATHETER, AS PER THE IFU THE STENT SHOULD BE LOADED ONTO A WIREGUIDE AND PUSHED INTO POSITION IN SHORT 2CM INCREMENTS WITH A PUSHING CATHETER. PRODUCT MANAGEMENT HAVE BEEN NOTIFIED TO CONSIDER PROVIDING RETRAINING TO THE CUSTOMER TO AVOID FUTURE OCCURRENCES OF THIS USER ERROR EVENT. THE COMPLAINT IS NOT CONFIRMED AS THE FAILURE COULD NOT BE VERIFIED IN THE LABORATORY. FQC REVIEW: PRIOR TO DISTRIBUTION, ALL ZSO DEVICES ARE SUBJECTED TO 100% INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. SUMMARY: THE COMPLAINT IS NOT CONFIRMED AS THE FAILURE COULD NOT BE VERIFIED IN THE LABORATORY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT" AND "STENT KINKED/ BENT" AS PER (B)(4) TRANSLATION: THE INNER LUMEN OF THE STENT IS "TOO" SMALL. AS PER CC FORM: THE ZIMMON STENT HAVE NOT ENOUGH SPACE FOR A WIREGUIDE THE JAGWIRE GUIDEWIRE IS IN THE BILIARY DUCT. FIRST THE TAKE A GUIDING CATHETER OVER THE GUIDE WIRE, AFTER THAN SHE WILL THE ZIMMON STENT WITH A PUSHER OVER THE GUIDING CATHETER INTO THE SCOPE, BUT IT ISN'T POSSIBLE, "THEN" SHE TAKE THE GUIDING CATHETER OUT AND PUSH THE ZIMMON STENT WITH THE PUSHER OVER THE WIREGUIDE, IT ISN´T ALSO POSSIBLE.

    Description of Event or Problem · 0

    AS PER ESOKS TRANSLATION : THE INNER LUMEN OF THE STENT IS TO SMALL. AS PER CC FORM: THE ZIMMON STENT HAVE NOT ENOUGH SPACE FOR A WIREGUIDE THE JAGWIRE GUIDEWIRE IS IN THE BILIARY DUCT. FIRST THEY TAKE A GUIDING CATHETER OVER THE GUIDE WIRE, AFTER THAT SHE PUSHED THE ZIMMON STENT WITH A PUSHER OVER THE GUIDING CATHETER INTO THE SCOPE, BUT IT ISN'T POSSIBLE, THEN SHE TAKE THE GUIDING CATHETER OUT AND PUSH THE ZIMMON STENT WITH THE PUSHER OVER THE WIREGUIDE, IT ISN´T ALSO POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617991 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD G21637 C1408649 00827002216372

    Patients

    Seq Age Sex Outcome Treatment
    1