BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 10647843 · Received October 8, 2020

    Report

    Report Number
    3001845648-2020-00767
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    July 27, 2020
    Report Date
    February 3, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K163018 CANCELLATION REPORT BEING SUBMITTED FOLLOWING CONFIRMATION FROM QUALITY THAT THE USE OF AN INCORRECT SIZE WIRE GUIDE COULD HAVE CONTRIBUTED TO THE DEPLOYMENT ISSUES NOTED IN (B)(4) (FDA REF NO. 3001845648-2020-00640).

    Description of Event or Problem · 0

    CANCELLATION REPORT BEING SUBMITTED FOLLOWING CONFIRMATION FROM QUALITY THAT THE USE OF AN INCORRECT SIZE WIRE GUIDE COULD HAVE CONTRIBUTED TO THE DEPLOYMENT ISSUES NOTED IN (B)(4) (FDA REF NO. 3001845648-2020-00640).

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K163018. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    DIFFICULTIES OF DEPLOYMENT WITH THE 2ND STENT. DEFECTIVE RELEASE AFTER SEVERAL TEST : TOO LONG PART OF THE STENT IN THE DUODENUM. NEED TO CUT THE METAL STENT (WITH ARGON). THIS REPORT IS BEING SUBMITTED TO DOCUMENT - USER ERROR: INCORRECT SIZE WIREGUIDE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112469 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1