BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE CATHETER

    MDR report key: 10512992 · Received September 10, 2020

    Report

    Report Number
    3001845648-2020-00517
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Report Date
    October 12, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE RPN OF THIS DEVICE IS UNKNOWN THE 510K # FOR THE ENBD PRODUCT FAMILY IS K180868 DEVICE EVALUATION THE UNKNOWN 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 RPN AND LOT NUMBER ARE UNKNOWN THIS FILE WILL BE ASSESSED AS AN ENBD DEVICE. DOCUMENT REVIEW AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ¿RPN¿ 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 (IFU0099-0) STATES THE FOLLOWING: ¿THIS DEVICE IS USED 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. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO THE USER NOT READING OR FOLLOWING THE IFU. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE DEVICE WAS USED PERCUTANEOUSLY. AS PER THE IFU, THE DEVICE IS NOT INDICATED FOR PERCUTANEOUS USE. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THIS REPORT BEING SUBMITTED IS A CORRECTION FOLLOW UP MDR AS THE INVESTIGATION CONCLUSIONS WERE OMITTED IN ERROR.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. AS THE RPN OF THIS DEVICE IS UNKNOWN THE 510K # FOR THE ENBD PRODUCT FAMILY IS K180868.

    Description of Event or Problem · 1

    GRACIENT A ET AL ¿¿RENDEZVOUS TECHNIQUE FOR TREATING BILIARY FISTULA¿. OFF LABEL USE: AN 8-CM BILIARY FULLY-COVERED SELF-EXPANDING METAL STENT WAS INSERTED, IN ORDER TO DECREASE PRESSURE ON THE BILIARY DUCT. IN ORDER TO AVOID MIGRATION, A 14-CM DUODENAL COVERED STENT (HANAROSTENT®, LIFE PARTNERS EUROPE, BAGNOLET, FRANCE) WAS POSITIONED NEXT TO THE BILIARY STENT¿S DISTAL PORTION. NEXT, A 12-CM, 8.5 FRENCH PLASTIC COTTON-LEUNG BILIARY STENT (COOK IRELAND LTD) WAS PLACED INTO THE COVERED SELF-EXPANDING METAL STENT THROUGH THE DUODENAL STENT (IN ORDER TO AVOID MIGRATION OF THE LATTER) AND LOCATED NEXT TO THE INLET OF THE EXTERNAL DRAIN. AFTER BILE FLOW THROUGH THE EXTERNAL DRAIN HAD FALLEN SIGNIFICANTLY (BY DAY 7 FOLLOWING THE COMBINED PROCEDURE), THE DRAIN WAS CLAMPED AND THEN REMOVED A FEW DAYS LATER. THE STENTS WERE REMOVED 45 D AFTER THEIR IMPLEMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982965 LIGUORY NASAL BILIARY DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR