BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET RADIOPAQUE TIP

    MDR report key: 15122486 · Received July 28, 2022

    Report

    Report Number
    3001845648-2022-00488
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    June 29, 2022
    Report Date
    November 16, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    510K: K180868. DEVICE EVALUATION THE ENBD-7-LIGUORY-RT DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW AS THE LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ENBD-7-LIGUORY-RT DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. 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

    AFTER STONE REMOVAL, THE PHYSICIAN TRIED TO INSERT ENBD CATHETER TO DRAIN CBD AND IHD. HOWEVER, ENBD CATHETER COULDN'T PUSH FORWARD TO(OR DIDN'T GET THROUGH) INTRA HEPATIC DUCT. THE PHYSICIAN PUSHED CATHETER SEVERAL TIMES, BUT FAILED. SO HE CHANGED ENBD-5-LIGUORY-RT. 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. 1.1.2 WHAT WAS FLUSHED THROUGH THE DEVICE (WATER, SALINE, CONTRAST, ETC.)? SALINE USED. 1.1.3 WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? TAEWOONG OPTIMOS WIRE 0.035 STRAIGHT. 1.1.4 IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? HE USED ENBD-5 OF COOK.. 1.2 FOR COMPLAINTS OCCURRING DURING PLACEMENT AND/OR USE, ALSO ASK: 1.2.1 WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED DURING THE PROCEDURE? OLYMPUS, TJF-260. 1.2.2 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE INTO POSITION? NO, IT WASN'T. 1.2.3 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DRAINAGE CATHETER INTO POSITION? YES, IT WAS. 1.2.4 WAS A DRAINAGE CATHETER LOOP PLACED IN THE DESCENDING PORTION OF THE DUODENUM? NO, IT WASN'T. 1.2.5 AFTER PLACEMENT, WAS DRAINAGE CATHETER POSITION VERIFIED? IT DIDN'T PLACE AT ALL. 1.2.5.1 IF YES, PLEASE DESCRIBE HOW. 1.2.6 PLEASE ESTIMATE AMOUNT OF TIME THE DRAINAGE CATHETER WAS IN PLACE PRIOR TO THIS OCCURRENCE. ABOUT 10 MINUTES. 1.2.7 DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? NO.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6)2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333803 LIGUORY NASAL BILIARY DRAINAGE SET RADIOPAQUE TIP FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown