BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET

    MDR report key: 10029122 · Received May 6, 2020

    Report

    Report Number
    3001845648-2020-00280
    Event Type
    Injury
    Date Received
    May 6, 2020
    Date of Event
    January 1, 2013
    Report Date
    August 31, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE RPN OF THIS DEVICE IS UNKNOWN THE 510K # FOR THE ENBD PRODUCT FAMILY IS K180868. DEVICE EVALUATION 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. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW 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 ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0099-0). IMAGE REVIEW ¿ N/A. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE PATIENT¿S RECEIVING CANCER TREATMENT POST STENT PLACEMENT. IT IS POSSIBLE THAT IF THE PATIENTS RECEIVED ANY FORM OF TREATMENT FOR THEIR CANCER (E.G. CHEMOTHERAPY) IT MAY HAVE RESULTED IN THEIR TUMOURS SHRINKING AND THE DRAINAGE CATHETERS MIGRATING/DISLOCATING. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS REQUIRED INTERVENTION TO EXCHANGE THE DRAINAGE CATHETERS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    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. 7 CASES OF ENBD DISLOCATION REQUIRING ENBD EXCHANGE THIS REPORT BEING SUBMITTED IS A COMPLETE FOLLOW UP REPORT AFTER THE INVESTIGATION WAS SIGNED OFF ON 31-AUG-2020.

    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. 7 CASES OF ENBD DISLOCATION REQUIRING ENBD EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491587 LIGUORY NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention