BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COTTON-LEUNG BILIARY STENT

    MDR report key: 24802281 · Received April 7, 2026

    Report

    Report Number
    3001845648-2026-00133
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    November 12, 2024
    Report Date
    March 10, 2026
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    CHO ET AL. REPORTED A CASE WHERE GUIDEWIRE WAS SUCCESSFULLY INSERTED ABOVE THE ANASTOMOTIC SITE, SUBSEQUENT PROCEDURES SUCH AS BALLOON DILATATION AND PLASTIC STENT (COTTON-LEUNG BILIARY STENT; COOK MEDICAL, BLOOMINGTON, IND, USA) INSERTION WERE PERFORMED. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED BEFORE ERCP IN ALL PATIENTS AS PER THE AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY RECOMMENDATION.19 HOWEVER, INDOMETHACIN WAS NOT ADMINISTERED BY ANY ROUTE TO PREVENT POST-ERCP PANCREATITIS BECAUSE IT IS NOT AVAILABLE IN KOREA. EARLY STENT MIGRATION WITHIN 1 MONTH OCCURRED IN 2 PATIENTS (5.4%), NEITHER OF WHOM REQUIRED REINTERVENTION. THIS COMPLAINT WAS OPENED TO CAPTURE THE STENT MIGRATION. THIS PROSPECTIVE STUDY INCLUDED 40 LDLT PATIENTS UNDERGOING ERCP WITH SOC (SPYGLASS DS II; BOSTON SCIENTIFIC CORP, NATICK, MASS, USA) TO TREAT ABSS WHEN GUIDEWIRE PLACEMENT ACROSS THE ABS WAS DIFFICULT DURING CONVENTIONAL ERCP (CANNULATION TIME >10 MINUTES) BETWEEN OCTOBER 2021 AND MAY 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857404 COTTON-LEUNG BILIARY STENT FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown