BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET RADIOPAQUE TIP

    MDR report key: 12157150 · Received July 13, 2021

    Report

    Report Number
    3001845648-2021-00551
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    June 4, 2021
    Report Date
    December 22, 2021
    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

    PMA/510(K) # - (B)(4). DEVICE EVALUATION THE ENBD-5-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. LAB EVALUATION ¿ N/A 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 ALL ENBD-5-LIGUORY-RT DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THE PRODUCT LABEL INDICATES TO THE USER THAT A 0.035¿ WIRE GUIDE SHOULD BE USED WITH THE DRAINAGE CATHETER. THE INSTRUCTIONS FOR USE (IFU0099-0) INSTRUCTS THE USER TO ¿REFER TO PACKAGE LABEL FOR MINIMUM CHANNEL SIZE REQUIRED FOR THIS DEVICE.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW ¿ N/A ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF USER ERROR WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE AVAILABLE INFORMATION IT IS KNOWN THAT A 0.025¿ WIRE GUIDE WAS USED WITH THE COMPLAINT DEVICE. AS PER THE PRODUCT LABEL, A 0.035¿ WIRE GUIDE IS RECOMMENDED FOR US WITH THIS DEVICE. IT IS POSSIBLE THAT THE USE OF A NON-RECOMMENDED WIRE GUIDE RESULTED IN INSUFFICIENT SUPPORT AS THE DRAINAGE CATHETER WAS ADVANCED THROUGH THE PATIENT¿S DIFFICULT ANATOMY RESULTING IN THE TIP OF THE DEVICE BECOMING KINKED. 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

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

    Additional Manufacturer Narrative · 1

    510(K) NUMBER: K180868. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    DR. (B)(6) TRIED TO INSERT AN ENBD INTO THE CBD, BUT THE TIP WAS KINKED DUE TO STRICTURE. SO DR.(B)(6) USED ANOTHER ENBD 5FR. TO FINISH THE PROCEDURE. 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 FOR ALL COMPLAINTS, ASK: 1.1.1 WAS THE DEVICE FLUSHED BEFORE USE? YES. 1.1.2 WHAT WAS FLUSHED THROUGH THE DEVICE (WATER, SALINE, CONTRAST, ETC.)? SALINE. 1.1.3. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? 1.1.4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? OLYMPUS VISIGLIDE2 STRAIGHT TYPE G/W 0.025" & 450CM. 1.1.5. WHAT WAS THE TARGET LOCATION IN THE BODY FOR USE OF THIS DEVICE? CBD. 1.1.6. WAS THE PATIENT¿S ANATOMY TORTUOUS? NO. 1.2 IN RELATION TO 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-260V. 1.2.2 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE INTO POSITION? YES. 1.2.3 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DRAINAGE CATHETER INTO POSITION? YES. 1.2.4 WAS A DRAINAGE CATHETER LOOP PLACED IN THE DESCENDING PORTION OF THE DUODENUM? NO. 1.2.5 AFTER PLACEMENT, WAS DRAINAGE CATHETER POSITION VERIFIED? N/A. 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. N/A. 1.2.7 DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058412 LIGUORY NASAL BILIARY DRAINAGE SET RADIOPAQUE TIP FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown