BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET

    MDR report key: 12673262 · Received October 21, 2021

    Report

    Report Number
    3001845648-2021-00733
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Report Date
    December 30, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510K # - K180868. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K180868 DEVICE EVALUATION THE ENBD DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. AS THE LOT NUMBER OF THE COMPLAINT DEVICES ARE UNKNOWN A REVIEW OF THE MANUFACTURING RECORDS CANNOT BE CARRIED OUT. HOWEVER, PRIOR TO DISTRIBUTION ENBD DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE ((B)(4)) STATES THE FOLLOWING: ¿INTENDED USE: THE NASAL BILLARY DRAINAGE SET IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THE USE OF THE ENBD DEVICE TO FACILITATE DELIVERY OF HIGH-DOSE INTRADUCTAL BRACHYTHERAPY IN CHOLANGIOCARCINOMA IS OFF LABEL USE. A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO THE OFF LABEL USE OF THE DEVICE. THE USE OF THE ENBD DEVICE TO FACILITATE DELIVERY OF HIGH-DOSE INTRADUCTAL BRACHYTHERAPY IN CHOLANGIOCARCINOMA IS OFF LABEL USE, WHEN A DEVICE IS USED OUTSIDE OF ITS VALIDATED STATE IT IS NOT POSSIBLE TO STATE HOW IT WILL PERFORM. THE MIGRATION EXPERIENCED BY 2 PATIENTS IS CONNECTED TO THE OFF LABEL USE. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, 2 OF THE PATIENTS EXPERIENCED MIGRATION WITH NO OTHER ADVERSE EFFECTS REPORTED DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    YUNG-LUN CHIN, 2021 ¿ENDOSCOPIC TECHNIQUES AND COMMON PITFALLS FOR NASOBILIARY CATHETER PLACEMENT TO FACILITATE DELIVERY OF HIGH-DOSE INTRADUCTAL BRACHYTHERAPY IN CHOLANGIOCARCINOMA¿ WE PREFERENTIALLY PLACE BILATERAL NBCS IN ALL PATIENTS TO MAXIMIZE THERAPY DELIVERY AND EFFICACY. SELECTIVE DILATION OF THE STRICTURE AREAS OF THE BILIARY TREE ARE UNDERTAKEN WITH A BALLOON DILATOR OF THE APPROPRIATE DIAMETER (HURRI-CANE RX; BOSTON SCIENTIFIC, MARLBOROUGH, MASS, USA) BEFORE PLACEMENT OF AN 8.5F OR 10F 250-CM NBC (NO. ENDB-10; COOK IRELAND INC, LIMERICK, IRELAND) BETWEEN 2007 AND 2017, 122 PATIENTS UNDERWENT ENDOSCOPIC NBC INSERTION, WITH A TOTAL OF 3 PROCEDURE FAILURES 2 CASES OF CATHETER MIGRATION BETWEEN NBC PLACEMENT AND TIME OF BRACHYTHERAPY AND 1 CASE OF FAILURE OF THE HDR AFTERLOADER TO ADVANCE THE RADIATION SOURCE TO THE DESIRED TREATMENT SITE). OFF LABEL USE: USE OF THE ENBD TO FACILITATE DELIVERY OF HIGH-DOSE INTRADUCTAL BRACHYTHERAPY IN CHOLANGIOCARCINOMA. THIS PR WILL CAPTURE 122 CASES OF OFF LABEL USE AND 2 CASES OF MIGRATION OF THE UNKNOWN ENBD.*

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571274 LIGUORY NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown