BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COTTON-LEUNG BILIARY STENT

    MDR report key: 18864442 · Received March 8, 2024

    Report

    Report Number
    3001845648-2024-00085
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    May 12, 2022
    Report Date
    March 29, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CANCELLATION REPORT IS BEING SUBMITTED FOR THIS COMPLAINT. THIS COMPLAINT CAPTURES EVENTS THAT OCCURRED IN THE "WANG ET. AL, 2020" LITERATURE PAPER. THE"SHIN HEE KIM ET. AL, 2019 "ARTICLE, WAS REFERENCED IN THIS LITERATURE PAPER. THIS "SHIN HEE KIM ET. AL, 2019" LITERATURE ARTICLE WAS NOT AVAILABLE TO COOK IRELAND AT THE TIME OF REPORTING THE WANG ET. AL, 2020 LITERATURE PAPER. ADDITIONAL COMPLAINTS HAVE NOW BEEN OPENED IN RELATION TO THE "SHIN HEE KIM ET. AL, 2019" ARTICLE, AS THIS IS THE ARTICLE IN WHICH THE ADVERSE EVENTS OCCURRED AND THE "WANG ET. AL, 2020" WAS A RETROSPECTIVE SUMMARY OF RELATED CASES FOUND IN LITERATURE. REFERENCE PR (B)(4) / MDR REF# (B)(4). THIS COMPLAINT IS NO LONGER REQUIRED.

    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

    CANCELLATION REPORT IS BEING SUBMITTED FOR THIS COMPLAINT. THIS COMPLAINT CAPTURES EVENTS THAT OCCURRED IN THE "WANG ET. AL, 2020" LITERATURE PAPER. THE"SHIN HEE KIM ET. AL, 2019 "ARTICLE, WAS REFERENCED IN THIS LITERATURE PAPER. THIS "SHIN HEE KIM ET. AL, 2019" LITERATURE ARTICLE WAS NOT AVAILABLE TO COOK IRELAND AT THE TIME OF REPORTING THE WANG ET. AL, 2020 LITERATURE PAPER. ADDITIONAL COMPLAINTS HAVE NOW BEEN OPENED IN RELATION TO THE "SHIN HEE KIM ET. AL, 2019" ARTICLE, AS THIS IS THE ARTICLE IN WHICH THE ADVERSE EVENTS OCCURRED AND THE "WANG ET. AL, 2020" WAS A RETROSPECTIVE SUMMARY OF RELATED CASES FOUND IN LITERATURE. REFERENCE PR (B)(4) / MDR REF# (B)(4). THIS COMPLAINT IS NO LONGER REQUIRED.

    Description of Event or Problem · 0

    WANG ET AL., 2020 ¿ DUODENAL PERFORATIONS SECONDARY TO A MIGRATED BILIARY PLASTIC STENT SUCCESSFULLY TREATED BY ENDOSCOPE: CASE-REPORT AND REVIEW OF THE LITERATURE. PERFORATION-RELATED SIGNS AND SYMPTOMS: DISTENDED ABDOMEN AND DIFFUSE ABDOMINAL TENDERNESS. DIAGNOSTIC METHOD: CT. THERAPEUTIC METHOD: ENDOSCOPIC REMOVAL OF PS BY USING SNARE AND CLOSURE OF PERFORATION BY HEMOCLIPS. THIS COMPLAINT WAS OPENED TO CAPTURE 1 PATIENT WHO EXPERIENCED PERFORATION WHICH INVOLVED A CLSO. THIS COMPLAINT WAS OPENED DUE TO LITERATURE REVIEWED BY WANG ET. AL, 2020 IN TABLE 2 SUMMARY OF RELATED CASES FOUND IN THE LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2172046 COTTON-LEUNG BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention