BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET

    MDR report key: 10029164 · Received May 6, 2020

    Report

    Report Number
    3001845648-2020-00281
    Event Type
    Injury
    Date Received
    May 6, 2020
    Date of Event
    January 1, 2013
    Report Date
    November 13, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ENBD 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 LIST OBSTRUCTION OF THE PANCREATIC DUCT AND BLOCKAGE OF THE DRAINAGE CATHETER AS KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH ERCP PROCEDURES AND NASAL BILIARY DRAINAGE. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. POSSIBLE ROOT CAUSES COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS, DISEASE PROGRESSION AND/OR THE CATHETER DISLOCATING FROM ITS TARGET LOCATION DUE TO THE PATIENT'S MOVEMENT(S). AS PER THE IFU, OBSTRUCTION OF THE PANCREATIC DUCT AND BLOCKAGE OF THE DRAINAGE CATHETER ARE KNOWN POTENTIAL ADVERSE EVENTS OF ERCP AND NASAL BILIARY DRAINAGE PROCEDURES. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, 06 PATIENTS REQUIRED ADDITIONAL PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE AND 04 PATIENTS REQUIRED ADDITIONAL ENBD DEVICE PLACEMENT AS A RESULT OF THIS EVENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THIS SUPPLEMENT FOLLOW-UP REPORT IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. KAWASHIMA ET AL 2013 - PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE IN 164 CONSECUTIVE PATIENTS WITH SUSPECTED PERIHILAR CHOLANGIOCARCINOMA TO ASSESS THE CLINICAL BENEFITS OF PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) IN PATIENTS WITH PERIHILAR CHOLANGIOCARCINOMA. THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ENBD (RPN UNKNOWN), ENBD-5 LIGUORY, ENBD-5 LIGUORY-RT, ENBD-7, ENBD-7 LIGUORY-C, ENBD-7-LIGUORY-RT, ENBD-7-NAG-C. POOR DRAINAGE EFFECT OF ENBD IN 10 PATIENTS. ADDITIONAL PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (N=6), ADDITIONAL ENBD PLACEMENT (N=4).

    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

    KAWASHIMA ET AL 2013 - PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE IN 164 CONSECUTIVE PATIENTS WITH SUSPECTED PERIHILAR CHOLANGIOCARCINOMA TO ASSESS THE CLINICAL BENEFITS OF PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) IN PATIENTS WITH PERIHILAR CHOLANGIOCARCINOMA. THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ENBD (RPN UNKNOWN), ENBD-5 LIGUORY, ENBD-5 LIGUORY-RT, ENBD-7, ENBD-7 LIGUORY-C, ENBD-7-LIGUORY-RT, ENBD-7-NAG-C. POOR DRAINAGE EFFECT OF ENBD IN 10 PATIENTS. ADDITIONAL PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (N=6). ADDITIONAL ENBD PLACEMENT (N=4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492610 LIGUORY NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention