BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 518 BILIARY SELF-EXPANDING STENT

    MDR report key: 13791401 · Received March 17, 2022

    Report

    Report Number
    3001845648-2022-00157
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    February 18, 2022
    Report Date
    July 8, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002314419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K182980. DEVICE EVALUATION: THE ¿ZIB5-125-4.0-60¿ DEVICE OF LOT NUMBER C1819969 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: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 28 MARCH 2022. R IN SUMMARY THE FOLLOWING RESULTS WERE OBSERVED IN THE LAB EVALUATION: ON EVALUATION OF THE DEVICE THE STENT WAS FULLY DEPLOYED ON RETURN, DEVICE APPEARED TO BE USED AND THE INNER CATHETER WAS OBSERVED TO BE FULLY EXTENDED. THE DEVICE FLUSHED WITH NO ISSUES, THE 18-INCH WIRE GUIDE PASSES THROUGH AS INTENDED AND THE INNER CATHETER WAS RETRACTED INTO THE DEVICE WITH NO ISSUES. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION ZIB5-125-4.0-60 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ZIB5-125-4.0-60 OF LOT NUMBER C1819969 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 C1819969 THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE (IFU0042). 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 DEVICE HANDLING TECHNIQUE BY THE USER. IT IS STATED THAT THE DEVICE CAME OFF OF THE CATHETER DURING THE PREPARATION PROCESS HENCE IT IS POSSIBLE THAT THE STENT WAS DEPLOYED DUE TO THE WAY THE USER HANDLED THE DEVICE. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THERE WAS NO PATIENT CONTACT. IT'S UNKNOWN HOW THE PROCEDURE WAS COMPLETED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "THE DEVICE CAME OFF OF THE CATHETER DURING THE PREPPING PROCESS. THERE WAS NO PATIENT CONTACT. IT'S UNKNOWN HOW THE PROCEDURE WAS COMPLETED." DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? PER DM, N/A. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? PER DM, N/A. PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? PER DM, N/A. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? PER DM, N/A. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. ZIB5 & ZIB6 - PER DM, N/A AND NO PATIENT CONTACT.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF A LAB EVALUATION ON 28-MAR-2022: VISUAL INSPECTION: STENT FULLY DEPLOYED ON RETURN, DEVICE APPEARS TO BE USED. THE INNER CATHETER WAS OBSERVED TO BE FULLY EXTENDED ON RETURN. FUNCTIONAL INSPECTION: DEVICE FLUSHES WITH NO ISSUES. THE 18 INCH WIRE GUIDE PASSES THROUGH AS INTENDED. INNER CATHETER WAS RETRACTED INTO THE DEVICE WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937091 ZILVER 518 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G31441 C1819969 10827002314419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown