BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 7812135 · Received August 24, 2018

    Report

    Report Number
    3001845648-2018-00395
    Event Type
    Malfunction
    Date Received
    August 24, 2018
    Date of Event
    July 26, 2018
    Report Date
    September 20, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K020788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K020788. 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)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K020788. 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. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K020788. (B)(4). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). CANCELLATION REPORT IS BEING SUBMITTED. FOLLOWING COMPLETION OF THE INVESTIGATION IT HAS BEEN DETERMINED THAT THE RISK INVOLVED IN THIS MALFUNCTION IS LOW (III). AS A RESULT THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY.

    Description of Event or Problem · 0

    THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "INNER CATHETER/ (PEEK) SEPARATION". AS REPORTED TO CUSTOMER RELATIONS "THERE IS A FLOPPY TIP ON THE EDGE OF THE DELIVERY SYSTEM. THE FLOPPY TIP SEPARATED FROM THE SHEATH INSIDE THE PATIENT'S BODY BUT DID NOT DETACH FROM THE DEVICE. WHEN HE WENT TO DEPLOY, HE WAS UNABLE TO DO SO. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE." ADDITIONAL INFORMATION RECEIVED 17-SEP-18: YES, THE DISTAL WHITE TIP. THE DISTAL EDGE OF THE CATHETER HAS A FLEXIBLE TIP THAT HAS A SEAMLESS TRANSITION WITH THE SHEATH. WHEN ADVANCING THE DEVICE THROUGH THE AMPULLA INTO THE COMMON BILE DUCT, THE ANGLE AND THE PRESSURE PLACED ON THE DEVICE CAN CAUSE THE FLOPPY TIP TO BEND TO THE POINT THAT IT MOVES COMPLETELY OUT OF THE SHEATH, WHICH EXPOSES THE EDGE OF THE SHEATH INSTEAD OF A SMOOTH TRANSITION.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS "THERE IS A FLOPPY TIP ON THE EDGE OF THE DELIVERY SYSTEM. THE FLOPPY TIP SEPARATED FROM THE SHEATH INSIDE THE PATIENT'S BODY BUT DID NOT DETACH FROM THE DEVICE. WHEN HE WENT TO DEPLOY, HE WAS UNABLE TO DO SO. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE". CONSERVATIVE MALFUNCTION REPORT BASED ON LIMITED INFORMATION RECEIVED.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. AS REPORTED TO CUSTOMER RELATIONS "THERE IS A FLOPPY TIP ON THE EDGE OF THE DELIVERY SYSTEM. THE FLOPPY TIP SEPARATED FROM THE SHEATH INSIDE THE PATIENT'S BODY BUT DID NOT DETACH FROM THE DEVICE. WHEN HE WENT TO DEPLOY, HE WAS UNABLE TO DO SO. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE." ADDITIONAL INFORMATION RECEIVED 17-SEP-18: YES, THE DISTAL WHITE TIP. THE DISTAL EDGE OF THE CATHETER HAS A FLEXIBLE TIP THAT HAS A SEAMLESS TRANSITION WITH THE SHEATH. WHEN ADVANCING THE DEVICE THROUGH THE AMPULLA INTO THE COMMON BILE DUCT, THE ANGLE AND THE PRESSURE PLACED ON THE DEVICE CAN CAUSE THE FLOPPY TIP TO BEND TO THE POINT THAT IT MOVES COMPLETELY OUT OF THE SHEATH, WHICH EXPOSES THE EDGE OF THE SHEATH INSTEAD OF A SMOOTH TRANSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656271 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1