BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET RADIOPAQUE TIP

    MDR report key: 12099684 · Received July 1, 2021

    Report

    Report Number
    3001845648-2021-00529
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 2, 2021
    Report Date
    December 14, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002224237
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE ENBD-5-LIGUORY-RT DEVICE OF LOT NUMBER C1809171 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ENBD-5-LIGUORY-RT 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 A REVIEW OF THE MANUFACTURING RECORDS FOR ENBD-5-LIGUORY-RT OF LOT NUMBER C1809171 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1809171. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0129-0). ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DIFFICULT PATIENT ANATOMY. IT IS POSSIBLE THAT A DIFFICULT PATIENT ANATOMY CAUSED OR CONTRIBUTED TO DIFFICULTY DURING ADVANCEMENT WHICH PREVENTED THE USER CROSSING THE STRICTURE WITH THE DEVICE. 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

    THEY TRIED TO INSERT ENBD-5 INTO THE INTRA HEPATICDUCT, BUT THE ENBD-5 DID NOT CROSS THE STRICTURE SITE. DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT BODY? NO DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE(S)? NO WERE THERE ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE ADVERSE EFFECT(S)? NO WAS THE DEVICE FLUSHED BEFORE USE? YES, IT WAS WHAT WAS FLUSHED THROUGH THE DEVICE (WATER, SALINE, CONTRAST, ETC.)? THEY USED SALINE . IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? UNKNOWN . DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? BOSTON SCIENTIFIC 0.035INCH JAG WIREGUIDE . WHAT WAS THE TARGET LOCATION IN THE BODY FOR USE OF THIS DEVICE? IN THE INTRA HEPATICDUCT . WAS THE PATIENT¿S ANATOMY TORTUOUS? UNKNOWN IN RELATION TO COMPLAINTS OCCURRING DURING PLACEMENT AND/OR USE ALSO ASK: THESE QUESTIONS BELOW ARE NOT RELEVANT TO THIS COMPLAINT. . WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED DURING THE PROCEDURE? OLYMPUS TJF260V . WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE INTO POSITION? UNKNOWN . WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DRAINAGE CATHETER INTO POSITION? YES, IT WAS . WAS A DRAINAGE CATHETER LOOP PLACED IN THE DESCENDING PORTION OF THE DUODENUM? UNKNOWN AFTER PLACEMENT, WAS DRAINAGE CATHETER POSITION VERIFIED? IF YES, PLEASE DESCRIBE HOW. UNKNOWN . PLEASE ESTIMATE AMOUNT OF TIME THE DRAINAGE CATHETER WAS IN PLACE PRIOR TO THIS OCCURRENCE. UNKNOWN . DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? UNKNOWN

    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
    999051 LIGUORY NASAL BILIARY DRAINAGE SET RADIOPAQUE TIP FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C1809171 10827002224237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown