BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 8183492 · Received December 20, 2018

    Report

    Report Number
    3001845648-2018-00610
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    November 26, 2018
    Report Date
    January 17, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002506241
    PMA / PMN Number
    K020788
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    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

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER: E2016031. INFORMATION1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: THE ZILBS-635-10-8 DEVICE OF LOT NUMBER C1440863 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THERE WAS A KINK ON THE FLEXOR PRESENT AT 54CM FROM THE WHITE CONNECTOR CAP. THE KINK POSSIBLY THEN RESULTED IN THE DEVICE GETTING STUCK IN THE ENDOSCOPE WHICH IN TURN LEAD TO THE STENT GETTING DEPLOYED AND DAMAGED ON REMOVAL WITH BRUTE FORCE. DOCUMENT REVIEW: A REVIEW OF INCOMING QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL ZILVER ZILBS DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1440863) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS 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 C1440863. AS PER "TAKE CARE NOT TO KINK THE DEVICE DURING USE." THERE IS NOT SUFFICIENT EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IT MAY BE NOTED THAT A PROJECT HAS BEEN INITIATED TO PREVENT THE REOCCURRENCE OF DEPLOYMENT, SEPARATION & ADVANCEMENT ISSUES SEEN IN ZILBS COMPLAINTS. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE KINK WHICH MAY HAVE BEEN CAUSED BY PRODUCT USE OR HANDLING. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THERE WAS A KINK PRESENT AT APPROXIMATELY 54CM FROM THE WHITE CONNECTOR CAP. THE KINK POSSIBLY THEN RESULTED IN THE DEVICE GETTING STUCK IN THE ENDOSCOPE WHICH IN TURN LEAD TO THE STENT GETTING DEPLOYED AND DAMAGED ON REMOVAL WITH BRUTE FORCE. 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

    USER ADVANCED THE DEVICE THROUGH WIRE GUIDE INTO ENDOSCOPY BUT STUCK WHILE THE HEAD OF THE DEVICE REACH THE EXIT OF ENDOSCOPY. USER CANNOT ADVANCE THE DEVICE OR WITHDRAW THE DEVICE FROM ENDOSCOPY AND TOOK 40 MINUTES EFFORT BUT FAILED. USER FINALLY PULL THE DEVICE OUT OF ENDOSCOPY WITH BRUTE FORCE WITH RED BUTTON IN PLACE (USER DIDN'T PULL THE RED BUTTON AT THE END OF DEVICE THE WHOLE TIME) USER FOUND OUT THE STENT WAS RELEASED FROM DELIVERY SYSTEM AND BROKEN.

    Description of Event or Problem · 0

    USER ADVANCED THE DEVICE THROUGH WIRE GUIDE INTO ENDOSCOPY BUT STUCK WHILE THE HEAD OF THE DEVICE REACH THE EXIT OF ENDOSCOPY. USER CANNOT ADVANCE THE DEVICE OR WITHDRAW THE DEVICE FROM ENDOSCOPY AND TOOK 40 MINUTES EFFORT BUT FAILED. USER FINALLY PULL THE DEVICE OUT OF ENDOSCOPY WITH BRUTE FORCE WITH RED BUTTON IN PLACE(USER DIDN'T PULL THE RED BUTTON AT THE END OF DEVICE THE WHOLE TIME) USER FOUND OUT THE STENT WAS RELEASED FROM DELIVERY SYSTEM AND BROKEN.

    Description of Event or Problem · 0

    USER ADVANCED THE DEVICE THROUGH WIRE GUIDE INTO ENDOSCOPY BUT STUCK WHILE THE HEAD OF THE DEVICE REACH THE EXIT OF ENDOSCOPY. USER CANNOT ADVANCE THE DEVICE OR WITHDRAW THE DEVICE FROM ENDOSCOPY AND TOOK 40 MINUTES EFFORT BUT FAILED. USER FINALLY PULL THE DEVICE OUT OF ENDOSCOPY WITH BRUTE FORCE WITH RED BUTTON IN PLACE(USER DIDN'T PULL THE RED BUTTON AT THE END OF DEVICE THE WHOLE TIME) USER FOUND OUT THE STENT WAS RELEASED FROM DELIVERY SYSTEM AND BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027424 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD G50624 C1440863 10827002506241

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention