BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET

    MDR report key: 10822408 · Received November 11, 2020

    Report

    Report Number
    3001845648-2020-00859
    Event Type
    Injury
    Date Received
    November 11, 2020
    Date of Event
    January 1, 2013
    Report Date
    March 30, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K180868. THIS IS A CANCELLATION REPORT. THE INFORMATION PREVIOUSLY REPORTED IN THIS MDR REPORT HAS NOW BEEN CONSOLIDATED INTO EMDR 3001845648-2020-00278. CURRENT MDR NO LONGER REQUIRED. CHANGES WERE CONFIRMED ON 30-MAR-21

    Description of Event or Problem · 0

    THIS IS A CANCELLATION REPORT. THE INFORMATION PREVIOUSLY REPORTED IN THIS MDR REPORT HAS NOW BEEN CONSOLIDATED INTO EMDR 3001845648-2020-00278. CURRENT MDR NO LONGER REQUIRED. CHANGES WERE CONFIRMED ON 30-MAR-21.

    Additional Manufacturer Narrative · 1

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

    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. THIS FILE WILL CAPTURE THE ONE PATIENT WITH GRADE 3 PANCREATITIS WHO DEVELOPED LIVER AND RENAL FAILURE. ALL DETAILS REGARDING THIS COMPLAINT WAS INITIALLY REPORTED UNDER 3001845648-2020-00278, HOWEVER THROUGH THE COURSE OF THE COMPLAINT INVESTIGATION IT WAS DECIDED AS PER COOKS INTERNAL COMPLAINT PROCESS TO SEPARATE THIS EVENT FOR THIS PARTICULAR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289076 LIGUORY NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention