BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 9516346 · Received December 24, 2019

    Report

    Report Number
    3001845648-2019-00771
    Event Type
    Malfunction
    Date Received
    December 24, 2019
    Date of Event
    November 25, 2019
    Report Date
    March 26, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002372709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K182980. DEVICE EVALUATION THE ZIB6-40-8-6.0 DEVICE OF LOT NUMBER C1623638 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 19 DECEMBER 2019. ON EVALUATION OF THE DEVICE THE INNER PEEK CATHETER WAS KINKED. FOLLOWING LAB EVALUATION THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: ¿THE CUSTOMER CONFIRMED THAT THE KINK WAS OBSERVED ON THE INNER PEEK CATHETER RATHER THAN OUTER SHEATH OF THE DEVICE. BECAUSE THE CUSTOMER THOUGHT THE OUTER SHEATH AND INNER CATHETER WAS A COMBINATION. JUST THE CUSTOMER¿S DESCRIPTION WAS INACCURATE; YES, THIS OCCURRED POST STENT-DEPLOYMENT (OUTSIDE OF THE PATIENT). KINK WAS OBSERVED AFTER THE USER DEPLOYED THE STENT. (OUTSIDE OF THE PATIENT); THE CUSTOMER SAID THAT THIS HOSPITAL IS A KEY TEACHING HOSPITAL WHICH UNDERTAKES TEACHING TASKS. DURING THIS PROCEDURE , A GRADUATE STUDENT PARTICIPATED IN THE AUXILIARY OPERATION. PRIOR TO USE, THE STUDENT ACCIDENTALLY REMOVED THE RED SAFETY, WHEN THE USER READY TO ADVANCE THE DELIVERY SYSTEM ALONG THE WIRE GUIDE, THE STENT WAS DEPLOYED ABOUT 1MM, SO THE USER DECIDED TO REPLACE ANOTHER NEW STENT TO FINISHED THE PROCEDURE, AND THE COMPLAINT STENT WAS USED AS A DEMO BY THE USER FOR PRACTICE. THE USER DEPLOYED THE WHOLE STENT AND FOUND THE INNER CATHETER WAS BENT. THE USER AGREE THAT THE OPERATION WAS NOT CONDUCTED WELL, BUT THEY DID NOT BELIEVE THAT THE INNER CATHETER WAS BENT DUE TO THE STENT DEPLOY; USUALLY, THEY WILL NOT USE THE NEW PRODUCT AS A DEMO. SOMETIMES, THEY WILL USE IT TO UNDERSTAND WORKING PRINCIPLE WHEN THE DEVICE HAVE BEEN USED¿ DOCUMENT REVIEW PRIOR TO DISTRIBUTION ZIB6-40-8-6.0 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. A REVIEW OF THE MANUFACTURING RECORDS FOR ZIB6-40-8-6.0 OF LOT NUMBER C1623638 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1623638. THE INSTRUCTIONS FOR USE (IFU0040-6) STATES THE FOLLOWING: "PRECAUTIONS ENSURE THAT THE SAFETY LOCK IS NOT INADVERTENTLY REMOVED UNTIL FINAL STENT RELEASE." THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF USER ERROR COULD BE DETERMINED FROM THE INFORMATION PROVIDED. FROM THE AVAILABLE INFORMATION IT IS KNOWN THAT THE JUNIOR DOCTOR REMOVED THE RED SAFETY TAB FROM THE DEVICE PRIOR TO PROCEDURE COMMENCEMENT. THIS RESULTED IN PARTIAL PREMATURE STENT DEPLOYMENT BEFORE THE TREATING PHYSICIAN COULD ADVANCE THE DEVICE OVER THE WIRE GUIDE TO BEGIN THE PROCEDURE. THE KINK IN THE INNER PEEK CATHETER HAD TO HAVE OCCURRED AFTER THE PROCEDURE WHEN DEPLOYED DURING THE DEMONSTRATION OUTSIDE THE PATIENT AS IF IT HAD OCCURRED PRIOR TO DEPLOYMENT THE OUTER SHEATH WOULD ALSO HAVE BEEN KINKED. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    PRIOR TO THE PROCEDURE, THE USER FOUND THE INTRODUCER OF THE DELIVERY SYSTEM WAS BENT , CHANGED ANOTHER NEW DEVICE TO FINISHED THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFO RECEIVED 06-MAR-2020: WHEN THE DEVICE WAS RETURNED TO CIRL AND EVALUATED IN THE LABORATORY NO KINKS/BENDS WERE OBSERVED ON THE INTRODUCER/OUTER SHEATH OF THE DEVICE. A KINK WAS OBSERVED ON THE INNER PEEK CATHETER (PLEASE SEE IMAGE BELOW). THE CUSTOMER CONFIRMED THAT THE KINK WAS OBSERVED ON THE INNER PEEK CATHETER RATHER THAN OUTER SHEATH OF THE DEVICE. BECAUSE THE CUSTOMER THOUGHT THE OUTER SHEATH AND INNER CATHETER WAS A COMBINATION. JUST THE CUSTOMER¿S DESCRIPTION WAS INACCURATE; CAN YOU CONFIRM IF THIS IS THE BEND/KINK THE USER OBSERVED ON THE DEVICE? YES, THIS OCCURRED POST STENT-DEPLOYMENT (OUTSIDE OF THE PATIENT). KINK WAS OBSERVED AFTER THE USER DEPLOYED THE STENT. (OUTSIDE OF THE PATIENT); IF THIS WAS NOT THE KINK/BEND THE USER OBSERVED CAN YOU PLEASE CONFIRM WHERE ON THE DEVICE THE USER OBSERVED THE KINK/BEND? THE CUSTOMER SAID THAT THIS HOSPITAL IS A KEY TEACHING HOSPITAL WHICH UNDERTAKES TEACHING TASKS. DURING THIS PROCEDURE , A GRADUATE STUDENT PARTICIPATED IN THE AUXILIARY OPERATION. PRIOR TO USE, THE STUDENT ACCIDENTALLY REMOVED THE RED SAFETY, WHEN THE USER READY TO ADVANCE THE DELIVERY SYSTEM ALONG THE WIRE GUIDE, THE STENT WAS DEPLOYED ABOUT 1MM, SO THE USER DECIDED TO REPLACE ANOTHER NEW STENT TO FINISHED THE PROCEDURE, AND THE COMPLAINT STENT WAS USED AS A DEMO BY THE USER FOR PRACTICE. THE USER DEPLOYED THE WHOLE STENT AND FOUND THE INNER CATHETER WAS BENT. THE USER AGREE THAT THE OPERATION WAS NOT CONDUCTED WELL, BUT THEY DID NOT BELIEVE THAT THE INNER CATHETER WAS BENT DUE TO THE STENT DEPLOY; IF THE BELOW KINK IS NOT WHAT THE USER OBSERVED CAN YOU CONFIRM IF THE KINK IN THE IMAGE BELOW WAS OBSERVED PRIOR TO DEVICE RETURN? USUALLY, THEY WILL NOT USE THE NEW PRODUCT AS A DEMO. SOMETIMES, THEY WILL USE IT TO UNDERSTAND WORKING PRINCIPLE WHEN THE DEVICE HAVE BEEN USED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. PMA/510(K) #: K182980.

    Description of Event or Problem · 1

    PRIOR TO THE PROCEDURE, THE USER FOUND THE INTRODUCER OF THE DELIVERY SYSTEM WAS BENT, CHANGED ANOTHER NEW DEVICE TO FINISHED THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311790 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C1623638 10827002372709

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR