BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL BILIARY DRAINAGE SET

    MDR report key: 20006109 · Received August 20, 2024

    Report

    Report Number
    3001845648-2024-00500
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    July 5, 2022
    Report Date
    August 23, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K180868 DEVICE EVALUATION: 18 X ENBD-8.5 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS COMPLAINT WAS RAISED FROM LITERATURE PAPER JAGIELSKI ET AT AL 2022 AND WILL CAPTURE THE OFF-LABEL USE OF ENBD-8.5 DEVICE. THIS FILE IS RELATED TO (B)(4). 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 STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ENBD-8.5 DEVICES ARE SUBJECT TO VISUAL 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0129) STATES THE FOLLOWING: ¿THE NASAL BILIARY DRAINAGE SET IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH THE 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 AS THE DEVICES WERE USED FOR TRANSMURAL DRAINAGE IN THE PANCREAS. AS PER THE IFU, THIS DEVICE IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. CONFIRMATION OF COMPLAINT THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE DEVICES WERE USED FOR TRANSMURAL DRAINAGE OF POST INFLAMMATORY PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS THIS IS OUTSIDE THE INTENDED USE OF THE DEVICE ¿ AS PER THE IFU NASAL BILIARY DRAINAGE SETS IS INTENDED FOR TEMPORARY 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. CLINICAL INPUT CONFIRMED THE OFF-LABEL USE OF THE DEVICE. SUMMARY FAILURE IDENTIFIED: OFF LABEL USE - 18 DEVICES CONFIRMED USED. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE DEVICES WERE USED FOR TRANSMURAL DRAINAGE OF POST INFLAMMATORY PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS THIS IS OUTSIDE THE INTENDED USE OF THE DEVICE ¿ AS PER THE IFU NASAL BILIARY DRAINAGE SETS IS INTENDED FOR TEMPORARY 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. CLINICAL INPUT CONFIRMED THE OFF-LABEL USE OF THE DEVICE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS DID NOT EXPERIENCE ANY HEALTH CONSEQUENCES OR ADVERSE EFFECTS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    JAGIELSKI ET AL 2022 (C) ¿ THE ROLE OF ANTIBIOTICS IN ENDOSCOPIC TRANSMURAL DRAINAGE OF POST-INFLAMMATORY PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS. PLACEMENT OF THE PANCREATICOGASTRIC OR PANCREATICODUODENAL ANASTOMOSIS IN THE FORM OF A TRANSMURAL CYSTOSTOMY WAS PERFORMED UNDER EUS GUIDANCE (JAGIELSKI ET AL., 2018; JAGIELSKI AND JACKOWSKI, 2021). THE ANASTOMOSIS BETWEEN THE GASTROINTESTINAL LUMEN AND THE COLLECTION CAVITY WAS CREATED USING A 10 FR CYSTOTOME (CYSTOTOME CST-10, COOK ENDOSCOPY INC., NORTH CAROLINA, USA) AND DILATED WITH A HIGH-PRESSURE BALLOON WITH A DIAMETER OF UP TO 15 MM (COOK ENDOSCOPY OR BOSTON SCIENTIFIC). THROUGH THE STOMY, A TRANSMURAL METAL JAGIELSKI ET AL. THE ANTIBIOTICS IN ENDOSCOPIC DRAINAGE OF PPPFCS. FOR ACTIVE TRANSMURAL DRAINAGE, A 7 FR OR 8.5 FR NASAL DRAIN (COOK ENDOSCOPY) AND 7 FR OR 8 FR DOUBLE PIGTAIL STENTS (COOK ENDOSCOPY) WERE INSERTED INTO THE COLLECTION CAVITY THROUGH THE LAMS. IN THE CASE OF PASSIVE (WITHOUT FLUSHING THROUGH NASOCYSTIC DRAINAGE) TRANSMURAL DRAINAGE, ONLY 7 FR OR 8.5 FR DOUBLE PIGTAIL STENTS (COOK ENDOSCOPY) WERE USED THROUGH LAMS. DRAINAGE SYSTEM. IF THE TRANSMURAL DRAINAGE SYSTEM DID NOT DRAIN THE ENTIRE NECROTIC AREA OR IF TRANSMURAL DRAINAGE WAS UNSUCCESSFUL FOR WOPN PATIENTS, DIRECT ENDOSCOPIC NECROSECTOMY WAS PERFORMED. THIS COMPLAINT CAPTURES THE OFF LABEL USE: USE OF ENBD FOR TRANSMURAL DRAINAGE OF POST INFLAMMATORY PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS. NO ADVERSE EFFECTS TO THE PATIENT NOTED IN THIS STUDY.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 23-AUG-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045666 NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male