BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 13192826 · Received January 7, 2022

    Report

    Report Number
    3001845648-2022-00006
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    November 12, 2021
    Report Date
    March 4, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002372693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ZIB6-40-8-4.0 DEVICE OF LOT NUMBER C1850168 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH ITS ORIGINAL BOX BUT WITHOUT THE POUCH. 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 (B)(6) 2021. ON EVALUATION OF THE DEVICE THE DISTAL WHITE TIP HAD A FISH MOUTH DAMAGE, AND A KINK WAS OBSERVED APPROX. 33.5CM FROM THE WHITE CONNECTOR CAP ON THE OUTER SHEATH. THE DEVICE FLUSHED AS EXPECTED. THE 0.035 SIZE WIRE GUIDE WOULD NOT PASS THE OUTER SHEATH APPROX. 64.5CM FROM THE PURPLE FLUSHING HUB. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZIB6-40-8-4.0 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ZIB6-40-8-4.0 OF LOT NUMBER C1850168 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. 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 IMPACT DURING TRANSPORTATION OR STORAGE. THIS IS LIKELY SO AS THE USER STATED THAT PRIOR TO USE THEY NOTICED THAT THE TIP OF THE STENT CARRIER WAS OVALIZED AND NOT ROUND. HE COULD NOT ADVANCE IT OVER THE WIRE GUIDE AND THE STENT WAS NOT INTRODUCED INTO THE PATIENT. THEY OPTED TO USE ANOTHER DEVICE. SUMMARY: THE 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

    ZILVER DEVICE DID NOT WORK. "AS PER CC FORM": PRIOR TO INTRODUCTION IN THE PATIENT, DR. (B)(6) NOTICED THAT THE TIP OF THE STENT CARRIER WAS OVALIZED AND NOT ROUND. HE COULD NOT ADVANCE IT OVER THE WIRE. THE STENT WAS NOT INTRODUCED IN THE PATIENT. HE THEN USED ANOTHER ZIB6-40-8-4.0 AND COULD PERFORMED THE PROCEDURE SUCCESSFULLY. DEVICE EVALUATED (B)(6) 2021: "DISTAL WHITE TIP DAMAGED. OUTER SHEATH KINKED". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    FOLLOW UP REPORT IS BEING SUBMITTED AS THE INVESTIGATION WAS CONCLUDED ON THE 04-MAR-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624526 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C1850168 10827002372693

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown