BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 6375640 · Received March 3, 2017

    Report

    Report Number
    3001845648-2017-00075
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Date of Event
    January 13, 2017
    Report Date
    February 2, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002372761
    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. PMA/510(K) # K163169. THE ZIB6-40-10-6.0 DEVICE OF LOT C1236727 RELATED TO THIS COMPLAINT WAS RETURNED WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE COMPLAINT DEVICE WAS ADVANCED OVER A TERUMO WIRE GUIDE OF 0.035¿ DIAMETER. HIGH RESISTANCE WAS ENCOUNTERED DURING DEPLOYMENT. THE PATIENT¿S BILIARY TRACT WAS TORTUOUS WITH TUMOUR COMPRESSION. PRE DILATION WAS NOT CONDUCTED PRIOR TO STENT DEPLOYMENT. THE DEVICE WAS FLUSHED PRIOR TO USE AS PER THE IFU. THE USER CONFIRMED THAT THE HANDLE WAS PULLED TOWARDS THE HUB DURING DEPLOYMENT, WITH RESISTANCE ENCOUNTERED. ON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT APPROXIMATELY 3CM OF THE STENT WAS DEPLOYED, AND 3CM OF THE STENT WAS NOT DEPLOYED. THE RED SAFETY TAB WAS IN PLACE. THE ENGINEERS COMPLETED THE STENT DEPLOYMENT IN THE LAB, WITH NO RESISTANCE ENCOUNTERED. IT WAS NOTED THAT THE DISTAL TIP HAD A SLIGHT BEND, AS DID THE PUSHER. THE OUTER CATHETER (FLEXOR) WAS SEPARATED FROM THE HANDLE AT THE WHITE CONNECTOR CAP. THE DEVICE WAS ABLE TO BE WIRED FREELY WITH A 0.035" DIAMETER WIRE GUIDE. THE CUSTOMER COMPLAINT IS CONFIRMED AS THE OUTER SHEATH WAS PULLED FROM THE HANDLE. ADDITIONAL QUESTIONS WERE ASKED OF THE CUSTOMER. FROM THE CUSTOMER RESPONSE, THE CUSTOMER DID NOT KNOW WHEN THE STENT WAS PARTIALLY DEPLOYED. THE PHYSICIAN REPORTED RESISTANCE WHEN WITHDRAWING THE DEVICE, AND HAD TO WITHDRAW THE DELIVERY SYSTEM AND THE WIRE GUIDE AS A UNIT. THE CUSTOMER CONFIRMED THAT THE RED SAFETY TAB WAS REMOVED PRIOR TO ATTEMPTING DEPLOYMENT. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE TORTUOUS PATIENT ANATOMY AND INSUFFICIENT STRENGTH OF THE FLEXOR. THE PATIENT ANATOMY COULD HAVE CAUSED THE RESISTANCE ENCOUNTERED DURING DEPLOYMENT. THIS RESISTANCE COULD HAVE LED TO HIGH DEPLOYMENT FORCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE FLEXOR SEPARATING FROM THE HANDLE. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL ZIB6 (ZILVER BILIARY) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED TO DATE, THERE IS NO EVIDENCE TO SUGGEST ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1236727. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE HANDLE OF DEVICE WAS SEPARATED WITH THE OUTER CATHETER, SO THE STENT CAN NOT RELEASED. THEN THE DOCTOR CHANGE ANOTHER NEW DEVICE TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160267 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD 10827002372761

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR