BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL PANCREATIC DRAINAGE SET

    MDR report key: 11963937 · Received June 9, 2021

    Report

    Report Number
    3001845648-2021-00445
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 21, 2017
    Report Date
    September 22, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K171623. DEVICE EVALUATION: THE NPDS-7 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 LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL NPDS- 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0107-2) STATES THE FOLLOWING: ¿THE NASAL PANCREATIC DRAINAGE SET IS USED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW ¿ N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF THE USER NOT READING OR FOLLOWING THE IFU WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE DEVICE WAS USED THROUGH THE STOMA AND FOR IRRIGATION PURPOSES RATHER THAN FOR DRAINAGE. THIS IS CONSIDERED OFF-LABEL USE. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K171623. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    JAGIELSKI ET AL 2017 ¿ENDOSCOPIC TREATMENT OF MULTILOCULAR WALLED-OFF PANCREATIC NECROSIS WITH THE MULTIPLE TRANSLUMINAL GATEWAY TECHNIQUE¿ A (B)(6) YEAR-OLD MALE PATIENT WAS ADMITTED TO THE OUR DEPARTMENT IN (B)(6) 2014 WITH PAIN OF THE ABDOMEN ACCOMPANIED WITH NAUSEA. THE PATIENT WAS ADMITTED TO OUR DEPARTMENT FOR AN EMERGENCY PROCEDURE AGAIN IN (B)(6) 2014 DUE TO SYMPTOMS OF INFECTED WALLED-OFF PANCREATIC NECROSIS. THE PRESENCE OF THREE WELL-DEFINED, PANCREATIC FLUID COLLECTIONS WITH NECROTIC CONTENTS WAS REVEALED IN CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CECT) OF THE ABDOMEN PERFORMED AT ADMISSION A STOMA BETWEEN THE GASTRIC LUMEN AND THE COLLECTION POSITIONED AT THE BORDER OF THE BODY AND TAIL OF THE PANCREAS WAS CREATED USING A CYSTOTOME (CYSTOTOME CST-10, WILSON-COOK, IRELAND) AND UNDER CONTROL OF ENDOSCOPIC ULTRASONOGRAPHY (EUS) (PENTAX EG3870UTK, JAPAN). THE GASTROCYSTOSTOMY WAS WIDENED USING A HIGH-PRESSURE BALLOON (BOSTON SCIENTIFIC, USA) TO THE DIAMETER OF 15 MM (PHOTO 2). THEREAFTER TWO 7 FR ENDOPROSTHESES (WILSON-COOK, IRELAND) AND A 7 FR NASAL DRAIN (WILSON-COOK, IRELAND) WERE GUIDED THROUGH THE STOMA INTO THE LUMEN OF THE COLLECTION FOR IRRIGATION PURPOSES THE SECOND ENDOSCOPIC PROCEDURE WAS PERFORMED AFTER 7 DAYS OF ACTIVE DRAINAGE. CONTRAST APPLIED THROUGH THE NASAL DRAIN DEMONSTRATED PARTIAL REGRESSION OF THE DRAINED NECROTIC COLLECTION. THE FACT THAT THE REMAINING TWO WALLED-OFF COLLECTIONS HELD ON DESPITE THE USE OF DRAINAGE WAS REVEALED ON THE ENDOSONOGRAPHY IMAGE. THE NEXT GASTROPANCREATIC FISTULA WAS PERFORMED DURING THE SAME PROCEDURE UNDER EUS CONTROL IN THE ANTRUM OF THE STOMACH. THEREAFTER TWO 7 FR ENDOPROSTHESES WERE GUIDED THROUGH THE FISTULA. REGRESSION OF NECROTIC COLLECTIONS WAS REVEALED IN CECT OF THE ABDOMEN, WHICH WAS PERFORMED AFTER TWO WEEKS. THE NEXT (THIRD) ENDOSCOPIC PROCEDURE WAS PERFORMED AFTER 17 DAYS OF ACTIVE DRAINAGE. TWO PANCREATIC STENTS (WILSON-COOK, IRELAND) WERE INSERTED TRANSPAPILLARY. LEAVING FOUR TRANSMURAL ENDOPROSTHESES AND TWO TRANSPAPILLARY PANCREATIC STENTS. DURING THE PERFORMED ENDOSCOPIC EXAMINATION IT WAS DECIDED TO REMOVE TRANSMURAL STENTS, DUE TO THE CLINICAL CONDITION AND THE RESULTS OF RADIOLOGICAL EXAMINATION. THE PREVIOUSLY GUIDED TRANSPAPILLARY PANCREATIC ENDOPROSTHESES WERE ALSO REMOVED. WHAT IS MORE, THE MAIN PANCREATIC DUCT WAS CONTRASTED AND NO LEAK INTO THE PERIPANCREATIC AREA WAS OBSERVED. AFTER 2 YEARS OF OBSERVATION THE PATIENT IS SAID TO BE IN GOOD GENERAL CONDITION, WITHOUT ANY SYMPTOMS. NO NEW RECURRENCE OF COLLECTIONS WAS OBSERVED LATER ON, DURING THE NEXT IMAGING EXAMINATIONS. THIS FILE IS BEING CREATED TO CAPTURE THE OFF LABEL USE OF NPDS-7 DEVICE AS IT WAS USED THROUGH THE STOMA AND FOR IRRIGATION AS OPPOSED TO DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863228 NASAL PANCREATIC DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR