BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL BILIARY DRAINAGE SET

    MDR report key: 11047057 · Received December 21, 2020

    Report

    Report Number
    3001845648-2020-00975
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    February 24, 2020
    Report Date
    October 11, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # 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 ALL ENBD 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 CIR. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0099-0) STATES THE FOLLOWING: ¿¿THIS DEVICE IS USED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF THE USER NOT READING/FOLLOWING THE IFU WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE AVAILABLE INFORMATION IT IS KNOWN THAT THE NASAL BILIARY DRAINAGE SET WAS PLACED VIA A TRANSGASTRIC OR TRANSDUODENAL PROCEDURE. AS PER THE INSTRUCTIONS FOR USE CLINICAL INPUT RECEIVED, THIS IS CONSIDERED OFF-LABEL USE. THE IFU STATES THAT THE DEVICE IS USED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH THE NASAL PASSAGE. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. NO KNOWN ADVERSE EFFECTS WERE REPORTED 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

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    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

    BARTHOLDY ET AL 2020 ¿ENDOSCOPIC TREATMENT WITH TRANSMURAL DRAINAGE AND NECROSECTOMY FOR WALLED-OFF NECROSIS PROVIDES FAVOURABLE LONG-TERM OUTCOMES ON PANCREATIC FUNCTION¿. WE RETROSPECTIVELY FOLLOW UP 125 PATIENTS WITH WALLED-OFF PANCREATIC NECROSIS TREATED WITH ENDOSCOPIC TRANSMURAL DRAINAGE AND NECROSECTOMY IN 2010¿2017. ALL PATIENTS RECEIVED PLASTIC PIGTAIL STENTS AND NASOCYSTIC CATHETER. ENDOSONOGRAPHY-GUIDED TRANSGASTRIC OR TRANSDUODENAL DRAINAGE WAS PERFORMED USING A CURVED LINEAR ARRAY ECHOENDOSCOPE OLYMPUS GF-UCT140-AL5 OR GF-UCT180/ALOKA SSD 5000 OR PROSOUND ALPHA 7 BY (A) NEEDLE PUNCTURE (ECHO- 19; COOK MEDICAL, BLOOMINGTON, IN), (B) FLUID ASPIRATION FOR MICROBIOLOGICAL DIAGNOSTICS, (C) INSERTION OF A GUIDEWIRE (0.03500 DREAMWIRE; BOSTON SCIENTIFIC, MARLBOROUGH, MA) THROUGH THE NEEDLE, (D) NEEDLE KNIFE INCISION OVER THE WIRE (HUIBREGTSE TRIPLE LUMEN; COOK MEDICAL), (E) BALLOON DILATION OF THE TRACT (CRE WIREGUIDED 12¿20 MM; BOSTON SCIENTIFIC), (F) PLACEMENT OF TWO DOUBLE PIGTAIL STENTS (ZIMMON 7 FR/6 CM; COOK MEDICAL) AND A NASOCYSTIC CATHETER (7- FR NASAL BILIARY DRAINAGE SET; COOK MEDICAL) FOR SUBSEQUENT IRRIGATION OF THE CAVITY. THE PIGTAIL STENTS WERE REMOVED ONE YEAR AFTER THE INDEX PROCEDURE. THE EXACT RPN OF THE NASAL BILIARY DRAINAGE SET¿ IS UNKNOWN POTENTIAL RPN¿S ARE ENBD-7, ENBD-7-C, ENBD-7-LIGUORY, ENBD-7-LIGUORY-RT, ENBD-7-NAG OR ENBD-7-NAG-C. THIS FILE IS CAPTURING THE OFF LABEL USE 125 CATHETERS WERE PLACED VIA TRANSGASTRIC OR TRANSDUODENAL PROCEDURES WHICH IS CONSIDERED OFF LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514175 NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male