BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE CATHETER

    MDR report key: 17754406 · Received September 15, 2023

    Report

    Report Number
    3001845648-2023-00719
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    June 15, 2023
    Report Date
    November 30, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K180868. DEVICE EVALUATION 1 X ENBD-7-LIGUORY-C DEVICE OF LOT NUMBER UNKNOWN WAS NOT RETURNED TO CIRL FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW AS THE LOT NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS COULD NOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ENBD-7-LIGUORY-C DEVICES ARE SUBJECT 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. HISTORICAL DATA NOT REVIEWED AS LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU0129) HIGHLIGHTS THE INTENDED USE: THE NASAL BILIARY DRAINAGE SET IS INTENDED FOR TEMPORARY ENDOSCOPIC ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. THE USER IS INSTRUCTED, DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE AVAILABLE INFORMATION IT IS KNOWN THE DEVICE WAS TO BE USED FOR INTRAOPERATIVE GUIDANCE DURING SURGERY TO REDUCE THE RISK OF BILE DUCT INJURY DURING LAPAROSCOPIC CHOLECYSTECTOMY. THIS OUTSIDE THE INTENDED USE OF THE DEVICE - TEMPORARY ENDOSCOPIC ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. AS PER THE IFU, THE USER IS INSTRUCTED NOT TO USE THE DEVICE FOR ANYTHING OTHER THAN THE INTENDED USE. COMPLAINT CONFIRMATION THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER AND/OR REP TESTIMONY. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER AND/OR REP TESTIMONY. FAILURE IDENTIFIED: OFF LABEL USE AND USER ERROR - 01 DEVICE CONFIRMED USED. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE AVAILABLE INFORMATION IT IS KNOWN THE DEVICE WAS TO BE USED FOR INTRAOPERATIVE GUIDANCE DURING SURGERY TO REDUCE THE RISK OF BILE DUCT INJURY DURING LAPAROSCOPIC CHOLECYSTECTOMY. THIS OUTSIDE THE INTENDED USE OF THE DEVICE - TEMPORARY ENDOSCOPIC ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. AS PER THE IFU, THE USER IS INSTRUCTED NOT TO USE THE DEVICE FOR ANYTHING OTHER THAN THE INTENDED USE. ACCORDING TO THE INITIAL REPORTER, THERE WERE NO HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 30-NOV-2023.

    Description of Event or Problem · 0

    ZHANG, 2023 ¿ MANAGEMENT OF RARE BILIARY DUCT VARIANTS USING A NASOBILIARY DRAINAGE TUBE AND WIRE-GUIDED NAVIGATION DURING LAPAROSCOPIC CHOLECYSTECTOMY: A CASE REPORT. BILIARY ANATOMICAL VARIATION IS AN IMPORTANT RISK FACTOR FOR BILE DUCT INJURY DURING LAPAROSCOPIC CHOLECYSTECTOMY [1]. IN THE PRESENT CASE, WE USED A NASOBILIARY DRAINAGE TUBE AND WIRE-GUIDED NAVIGATION TO IDENTIFY A RARE BILIARY VARIANT AND PROVIDE INTRAOPERATIVE GUIDANCE TO REDUCE THE RISK OF BILE DUCT INJURY DURING LAPAROSCOPIC CHOLECYSTECTOMY (VIDEO 1). A 29-YEAR-OLD WOMAN WAS ADMITTED WITH A 3-DAY HISTORY OF UPPER ABDOMINAL PAIN AND JAUNDICE. MAGNETIC RESONANCE CHOLANGIOPANCREATOGRAPHY REVEALED THAT THE CYSTIC DUCT INSERTED INTO THE RIGHT POSTERIOR SECTORAL DUCT (RPSD) AND A SUSPECTED STONE WAS LOCATED AT THE LOWER END OF THE COMMON BILE DUCT (FIG. 1). ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY CONFIRMED THE PRESENCE OF AN ABNORMAL JUNCTION BETWEEN THE CYSTIC DUCT AND RPSD (FIG. 2 A), CLASSIFIED AS TYPE 4A ACCORDING TO THE RIGHT HEPATIC DUCT VARIANT CLASSIFICATION BY HUANG ET AL. [2]. ATTEMPTS TO SELECTIVELY CANNULATE THE RPSD USING A SPHINCTEROTOME AND GUIDEWIRE WERE UNSUCCESSFUL. HOWEVER, WE SUCCESSFULLY CANNULATED THE RPSD USING A NASOBILIARY DRAINAGE TUBE (NASAL BILIARY DRAINAGE CATHETER, ENBD-7-LIGUORY-C; COOK, LIMERICK, IRELAND) AND WIRE-GUIDED NAVIGATION, CONFIRMING THE ABERRANT JUNCTION OF THE CYSTIC DUCT WITH THE RPSD (FIG. 2 B). DURING SURGERY, THE SURGEON INJECTED IN DOCYANINE GREEN THROUGH THENASOBILIARY CATHETER TO IDENTIFY THE RPSD AND AVOID ITS INJURY (FIG. 3). POSTOPERATIVE NASOBILIARY TUBE CHOLANGIOGRAPHY REVEALED UNOBSTRUCTED FLOW IN THE RPSD (FIG. 4). THIS COMPLAINT CAPTURES OFF LABEL USE DRAINAGE DEVICE USED FOR INTRAOPERATIVE GUIDANCE AND DURING SURGERY, THE SURGEON INJECTED IN DOCYANINE GREEN THROUGH THEN A SO BILIARY CATHETER TO IDENTIFY THE RPSD AND AVOID ITS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294523 LIGUORY NASAL BILIARY DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female