BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET

    MDR report key: 10028878 · Received May 6, 2020

    Report

    Report Number
    3001845648-2020-00278
    Event Type
    Injury
    Date Received
    May 6, 2020
    Date of Event
    January 1, 2013
    Report Date
    August 24, 2021
    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 IS UNKNOWN THE PMA/510(K)# FOR THE ENDB FAMILY IS K180868. DEVICE EVALUATION THE ENBD DEVICE OF UNKNOWN RPN AND 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 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 (IFU0099-0 / IFU0129-0) LISTS PANCREATITIS AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ERCP AND NASAL BILIARY DRAINAGE PROCEDURES. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS AND/OR THE PROCEDURE WHEREBY THE CATHETER WAS PLACED. AS PER THE IFU, PANCREATITIS IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ERCP AND NASAL BILIARY DRAINAGE PROCEDURES. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER ALL OF THE PATIENTS WITH GRADE 1 AND 2 POST-ENBD PANCREATITIS AND 2 OF THE 3 PATIENTS WITH GRADE 3 PANCREATITIS WERE CURED WITH CONSERVATIVE TREATMENT (I.E. FASTING, TRANSFUSIONS, AND ANTIBIOTICS). THE CLINICAL COURSE OF THESE 32 PATIENTS WAS IDENTICAL TO THAT OF THE PATIENTS WITHOUT POST-ENBD PANCREATITIS, EXCEPT FOR A PROLONGED FASTING PERIOD. THE REMAINING PATIENT WITH GRADE 3 POST-ENBD PANCREATITIS DEVELOPED LIVER AND RENAL FAILURE; THIS PATIENT EVENTUALLY BECAME INOPERABLE BECAUSE OF POOR GENERAL CONDITION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. AS THE RPN IS UNKNOWN THE PMA/510(K)# FOR THE ENDB FAMILY IS K180868. THIS IS A SUPPLEMENTAL FOLLOW UP MDR REPORT BEING SUBMITTED TO CAPTURE THE UPDATED DESCRIPTION OF EVENT ALONG WITH THE CHANGE IN QUANTITY OF DEVICES USED FROM 33 TO 32.

    Description of Event or Problem · 0

    FINAL MDR BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON (B)(6) 2021.

    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. 33 CASES OF POST ENBD PANCREATITIS, OF THE 164 PATIENTS (26 GRADE 1 PATIENTS, 4 GRADE 2 PATIENTS, AND 3 GRADE 3 PATIENTS). ALL OF THE PATIENTS WITH GRADE 1 AND 2 POST-ENBD PANCREATITIS AND 2 OF THE 3 PATIENTS WITH GRADE 3 PANCREATITIS WERE CURED WITH CONSERVATIVE TREATMENT (IE, FASTING, TRANSFUSIONS, AND ANTIBIOTICS). THE CLINICAL COURSE OF THESE 32 PATIENTS WAS IDENTICAL TO THAT OF THE PATIENTS WITHOUT POST-ENBD PANCREATITIS, EXCEPT FOR A PROLONGED FASTING PERIOD. THE REMAINING PATIENT WITH GRADE 3 POST-ENBD PANCREATITIS DEVELOPED LIVER AND RENAL FAILURE; THIS PATIENT EVENTUALLY BECAME INOPERABLE BECAUSE OF POOR GENERAL CONDITION. FROM THE MULTIVARIATE ANALYSIS, THE SIGNIFICANT RISK FACTORS FOR POST-ENBD PANCREATITIS INCLUDED UNDERGOING PANCREATOGRAPHY (P<0.001; 95% CI, 2.44¿31.1) AND THE ABSENCE OF PREVIOUS EBS OR ENBD (P < 0.001; 95% CI, 3.03¿29.2) (TABLE 4). ENBD REINSERTION DUE TO DISLOCATION OR OCCLUSION OF THE CATHETER WAS REQUIRED IN 16 PATIENTS. THIS FILE CAPTURES THE 32 PATIENTS WITH GRADE 1, 2 OR 3 PANCREATITIS WHO WERE TREATED CONSERVATIVELY AND CURED. THIS IS A SUPPLEMENTAL FOLLOW UP MDR REPORT BEING SUBMITTED TO CAPTURE THE UPDATED DESCRIPTION OF EVENT ALONG WITH THE CHANGE IN QUANTITY OF DEVICES USED FROM 33 TO 32.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. AS THE RPN IS UNKNOWN THE PMA/510(K)# FOR THE ENDB 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. 33 CASES OF POST ENBD PANCREATITIS, OF THE 164 PATIENTS (26 GRADE 1 PATIENTS, 4 GRADE 2 PATIENTS, AND 3 GRADE 3 PATIENTS). ALL OF THE PATIENTS WITH GRADE 1 AND 2 POST-ENBD PANCREATITIS AND 2 OF THE 3 PATIENTS WITH GRADE 3 PANCREATITIS WERE CURED WITH CONSERVATIVE TREATMENT (IE, FASTING, TRANSFUSIONS, AND ANTIBIOTICS). THE CLINICAL COURSE OF THESE 32 PATIENTS WAS IDENTICAL TO THAT OF THE PATIENTS WITHOUT POST-ENBD PANCREATITIS, EXCEPT FOR A PROLONGED FASTING PERIOD. THE REMAINING PATIENT WITH GRADE 3 POST-ENBD PANCREATITIS DEVELOPED LIVER AND RENAL FAILURE; THIS PATIENT EVENTUALLY BECAME INOPERABLE BECAUSE OF POOR GENERAL CONDITION. FROM THE MULTIVARIATE ANALYSIS, THE SIGNIFICANT RISK FACTORS FOR POST-ENBD PANCREATITIS INCLUDED UNDERGOING PANCREATOGRAPHY (P<0.001; 95% CI, 2.44¿31.1) AND THE ABSENCE OF PREVIOUS EBS OR ENBD (P < 0.001; 95% CI, 3.03¿29.2) (TABLE 4). ENBD REINSERTION DUE TO DISLOCATION OR OCCLUSION OF THE CATHETER WAS REQUIRED IN 16 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493559 LIGUORY NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention