BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASTIC BILIARY STENT

    MDR report key: 20310066 · Received September 26, 2024

    Report

    Report Number
    3001845648-2024-00579
    Event Type
    Injury
    Date Received
    September 26, 2024
    Report Date
    July 18, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K040151
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INITIALLY RAISED FROM A SURVEY, FOR MIGRATION ASSOCIATED WITH FS-PC (FUSION PUSHING CATHETER IN RELATION TO COOK PLASTIC BILIARY STENT. AS PER THE INFORMATION PROVIDED IN THE DESCRIPTION OF EVENTS, THE INITIAL REPORTER STATED ¿MIGRATION IS NOT HAPPENING IN CASE OF THE USE OF INTRODUCERS. I BELIEVE IT IS A MISTAKE AND THE DOCTOR WAS THINKING ABOUT THE STENT, BUT THAT IS NOT EXPLAINED¿. AS FS-PC (FUSION PUSHING CATHETERS) ARE NOT IMPLANTABLE DEVICES, THIS DEVICE COULD NOT HAVE MIGRATED. BASED ON THE INFORMATION PROVIDED, THE COMPLAINT HAS BEEN COMPLETED ON THE ASSUMPTION THAT THE MIGRATION WAS IN RELATION TO AN UNKNOWN PLASTIC BILIARY STENT THAT WAS USED WITH THE FUSION PUSHING CATHETER. SHOULD MORE INFORMATION BECOME AVAILABLE AT A LATER DATE, THE COMPLAINT CAN BE UPDATED ACCORDINGLY. DEVICE EVALUATION 01 COOK PLASTIC BILIARY STENT OF UNKNOWN RPN AND LOT NUMBER UNKNOWN WAS NOT RETURNED TO CIRL FOR EVALUATION. THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS AS THE LOT NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN, A REVIEW OF THE RELEVANT WORK ORDER COULD NOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. REVIEW HISTORICAL DATA HISTORICAL DATA COULD NOT BE REVIEWED AS LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL INSTRUCTIONS FOR USE, IFU0045, IFU0055 AND IFU0100 INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS ASSOCIATED WITH BILIARY STENT PLACEMENT. THESE IFU¿S LIST STENT MIGRATION AS AN ADDITIONAL COMPLICATION ASSOCIATED WITH THE USE OF THESE DEVICES. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH BILIARY STENT PLACEMENT AND THE USE OF THE DEVICE. AS PREVIOUSLY MENTIONED, THIS IS KNOWN POTENTIAL ADVERSE EVENT AS DESCRIBED IN THE INSTRUCTIONS FOR USE. CONFIRMATION OF COMPLAINT IS CONFIRMED BASED CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH BILIARY STENT PLACEMENT AND THE USE OF THE DEVICE. AS PREVIOUSLY MENTIONED, THIS IS KNOWN POTENTIAL ADVERSE EVENT AS DESCRIBED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    ON TWO OCCASIONS WE RECEIVED ANSWERS THAT MAY SUGGEST THE NEED TO RECORD COMPLAINT. HOWEVER, IT IS NOT OBVIOUS IF THERE IS AN ISSUE WITH THE DEVICES. 1. THE FIRST HCP WHO ANSWERED THE SURVEY STATED PLEASE PROVIDE A DESCRIPTION OF THE ISSUE(S) YOU ENCOUNTERED. - OTHER MIGRATION 11-20% OF THE TIME. MIGRATION IS NOT HAPPENING IN CASE OF THE USE OF INTRODUCERS. I BELIEVE IT IS A MISTAKE AND THE DOCTOR WAS THINKING ABOUT THE STENT, BUT THAT IS NOT EXPLAINED (B)(4). 2. ANSWERS PROVIDED: DID THE COOK STENT INTRODUCER PERFORM AS INTENDED? - NO. PLEASE PROVIDE A DESCRIPTION OF THE ISSUE(S) YOU ENCOUNTERED. - LACK OF PUSHABILITY. SHOULD BE MORE RIGID. THE REASON DESCRIBED DO NOT SUGGEST THE ISSUE WITH THE DEVICE. IT SUGGESTS THE OVERALL CHARACTERISTIC THAT UNFORTUNATELY WE OFTEN HERE ABOUT FS-PC AND FS-OA. "AS PER CC FORM": MIGRATION IS NOT HAPPENING IN CASE OF THE USE OF INTRODUCERS. I BELIEVE IT IS A MISTAKE AND THE DOCTOR WAS THINKING ABOUT THE STENT, BUT THAT IS NOT EXPLAINED. 2. ANSWERS PROVIDED: DID THE COOK STENT INTRODUCER PERFORM AS INTENDED? - NO. PLEASE PROVIDE A DESCRIPTION OF THE ISSUE(S) YOU ENCOUNTERED. - LACK OF PUSHABILITY. SHOULD BE MORE RIGID. THE REASON DESCRIBED DO NOT SUGGEST THE ISSUE WITH THE DEVICE. IT SUGGESTS THE OVERALL CHARACTERISTIC THAT UNFORTUNATELY WE OFTEN HERE ABOUT FS-PC AND FS-OA. PLEASE IDENTIFY HOW THE COOK STENT INTRODUCER CAUSED OR CONTRIBUTED TO THE UNSUCCESSFUL STENT PLACEMENT (S). COMPRESSED. BENT, KINKED OR DEFORMED INTRODUCER (B)(4). 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

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-JUL-25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263509 PLASTIC BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention