BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON-LEUNG BILIARY STENT

    MDR report key: 15083801 · Received July 22, 2022

    Report

    Report Number
    3001845648-2022-00450
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    February 6, 2022
    Report Date
    October 20, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    DEVICE EVALUATION: THE 1X COTTON-LEUNG BILIARY STENT DEVICE OF UNKNOWN RPN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO CAPTURE 'OCCLUSION' LAB EVALUATION: THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA REVIEW: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IFU & LABEL REVIEW: AS PER THE COTTON-LEUNG BILIARY STENT TECHNICAL CONTENT FORM, STENT OCCLUSION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BILIARY STENT PLACEMENT ¿THOSE ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: FEVER, OBSTRUCTION OF THE PANCREATIC DUCT, PAIN/DISCOMFORT, STENT MIGRATION, STENT OCCLUSION, TRAUMA TO THE BILIARY DUCT OR DUODENUM¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. HOWEVER, STENT OCCLUSION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BILIARY STENT PLACEMENT AS PER TECHNICAL CONTENT FORM. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE JOURNAL ARTICLE, THE PATIENT NEEDED TO UNDERGO AN UNSCHEDULED, EARLY SECOND ERCP PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    LEE, BILIARY DECOMPRESSION BY NASOBILIARY CATHETER OR BILIARY STENT IN ACUTE SUPPURATIVE CHOLANGITIS: A PROSPECTIVE RANDOMIZED TRIAL. ALL ERCPS WERE PERFORMED WITH A THERAPEUTIC DUODENOSCOPE (TJF-SERIES, OLYMPUS OPTICAL, CO., LTD., TOKYO, JAPAN) WITH A LARGE ACCESSORY CHANNEL. AFTER CANNULATION OF THE COMMON BILE DUCT AND CONFIRMATION OF THE PRESENCE OF STONES AND/OR OTHER PATHOLOGY, PATIENTS WERE RANDOMIZED. THE SPECIFICATIONS FOR THE STENT WERE 10F, ONE SIDE HOLE, AND STRAIGHT PLASTIC (COTTON-LEUNG BILIARY STENT, WILSON COOK). THE STENT BECAME OCCLUDED IN ONE PATIENT WHO HAD PURULENT BILE AT THE FIRST ERCP AND AFTER THE DRAINAGE PROCEDURE HAD PERSISTENT FEVER WITH AN INCREASING SERUM BILIRUBIN LEVEL. UNDERWENT AN UNSCHEDULED, EARLY SECOND ERCP TO TREAT THE CHOLANGITIS. UNDERWENT AN UNSCHEDULED, EARLY SECOND ERCP.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108957 COTTON-LEUNG BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention