BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 518 BILIARY SELF-EXPANDING STENT

    MDR report key: 6328718 · Received February 14, 2017

    Report

    Report Number
    3001845648-2017-00047
    Event Type
    Malfunction
    Date Received
    February 14, 2017
    Date of Event
    January 12, 2017
    Report Date
    January 17, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002313528
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    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 ZIB5-125-5.0-40 DEVICE OF LOT C1152849 WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT, AND THE RED SAFETY TAB WAS IN PLACE. THE CUSTOMER WAS ALSO ASKED FOR MORE INFORMATION ABOUT THE EVENT, BUT THIS WAS NOT PROVIDED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE DEVICE HANDLING, WHICH COULD CAUSE OR CONTRIBUTE TO THE PREMATURE DEPLOYMENT OF THE STENT. HOWEVER, THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION, ADDITIONAL INFORMATION WAS NOT PROVIDED AND THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, AND NO FURTHER COMMENT CAN BE MADE. ALL ZIB5 (ZILVER 518 BILIARY STENT) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS 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 THIS LOT NUMBER. ACCORDING TO CUSTOMER TESTIMONY, THIS INCIDENT OCCURRED PRIOR TO PATIENT CONTACT, AND 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

    IT WAS REPORTED WHILST ATTEMPTING TO PUT CATHETER OVER THE WIRE TIP OF CATHETER, STENT CAME OFF EXPOSING THE STENT. DID NOT ATTEMPT TO USE AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112150 ZILVER 518 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD 10827002313528

    Patients

    Seq Age Sex Outcome Treatment
    1