BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL PANCREATIC DRAINAGE SET

    MDR report key: 20254182 · Received September 19, 2024

    Report

    Report Number
    3001845648-2024-00491
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    January 17, 2018
    Report Date
    September 19, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K171623. DEVICE EVALUATION: 21X NPDS-7 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 2018 (C) AND WILL CAPTURE THE OFF-LABEL USE OF NPDS DEVICE. OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED 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 NPDS-7 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 (IFU0107) STATES THE FOLLOWING: ¿THE NASAL PANCREATIC DRAINAGE SET IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC 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 STENTS WERE INSERTED INTO THE CAVITY OF THE LUMEN FOR COLLECTION WITHIN THE NECROTIC CAVITY. 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. STENTS WERE INSERTED INTO THE CAVITY OF THE LUMEN FOR COLLECTION WITHIN THE NECROTIC CAVITY. THIS IS OUTSIDE THE INTENDED USE OF THE DEVICE AS PER THE IFU NASAL PANCREATIC DRAINAGE SETS ARE INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC 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 - (B)(4) DEVICES CONFIRMED USED. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. STENTS WERE INSERTED INTO THE CAVITY OF THE LUMEN FOR COLLECTION WITHIN THE NECROTIC CAVITY. THIS IS OUTSIDE THE INTENDED USE OF THE DEVICE AS PER THE IFU NASAL PANCREATIC DRAINAGE SETS ARE INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 19 SEP 2024.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: JAGIELSKI ET AL 2018 (C) ¿ ENDOSCOPIC TREATMENT OF WALLED-OFF PANCREATIC NECROSIS COMPLICATED WITH PANCREATICOCOLONIC FISTULA. SINCE 2011, THE PLACE OF FISTULOTOMY WAS CHOSEN UNDER EUS GUIDANCE. BETWEEN 2001 AND 2011 (CONVENTIONAL DRAINAGE), FISTULOTOMY WAS PERFORMED ON THE TOP OF THE LARGEST PROTUBERANCE OF THE NECROTIC COLLECTION INTO THE GASTROINTESTINAL WALL (65 PATIENTS). WHEN NO PROTUBERANCE WAS VISIBLE, THE DETERMINATION OF THE NECROGASTROSTOMY OR NECRODUODENOSTOMY SITE WAS MADE WITH THE HELP OF FLUOROSCOPY AFTER ADMINISTRATION OF CONTRAST MEDIUM EITHER VIA THE DUODENAL PAPILLA (IN THE PRESENCE OF A MAIN PANCREATIC DUCT LEAK) IN 32 PATIENTS OR THROUGH A PERCUTANEOUS DRAIN IN 15 PATIENTS. ENTEROSTOMY WAS PERFORMED WITH A 7 FRENCH FISTULOTOME (HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE HPC3, WILSON-COOK) OR A GIOVANNINI CYSTOSTOME (CYSTOTOME CST-10, WILSON-COOK). THE OPENING BETWEEN THE LUMEN OF THE GASTROINTESTINAL TRACT AND THE LUMEN OF THE NECROTIC COLLECTION WAS WIDENED WITH THE USE OF A ¿BOUGIE¿ TYPE DILATOR (SOEHENDRA BILIARY DILATION CATHETERS SBDC-8.5, SBDC10, WILSON-COOK) OR A HIGH-PRESSURE BALLOON (8 OR 20 MM, BOSTON SCIENTIFIC). A 7 FRENCH OR 8 FRENCH NASOCYSTIC DRAIN (BALTON OR WILSON-COOK) AND SEVERAL ¿DOUBLE-PIGTAIL¿ (7 FRENCH/8.5 FRENCH STENTS, WILSON COOK/MAR FLOW) OR 10 FRENCH STENTS BY WILSON COOK WERE INSERTED INTO THE CAVITY LUMEN OF THE COLLECTION. ERP WAS PERFORMED IN 18 OF 21 PATIENTS (85.71%). ENDOSCOPIC RETROGRADE PANCREATOGRAPHY (ERP) IN CASES OF A MAIN PANCREATIC DUCT (MPD) LEAK, SPHINCTEROTOMY WAS PERFORMED (OLYMPUS FLOWCUT KD-301Q0725 SPHINCTEROTOME) AND A PANCREATIC STENT WAS INSERTED INTO THE MAIN PANCREATIC DUCT (5¿10 FRENCH, GEENEN, ZIMMON PANCREATIC STENT, WILSON-COOK OR MAR FLOW). THE TRANSPAPILLARY PANCREATIC STENTS WERE EXCHANGED AFTER 3, 6, AND 12 MONTHS UNTIL NO LEAKAGE OF CONTRAST OUTSIDE THE DUCT COULD BE DEMONSTRATED. IN PATIENTS WITH ACTIVE TRANSPAPILLARY DRAINAGE, AFTER SPHINCTEROTOMY PERFORMED DURING ERP THE MAIN PANCREATIC DUCT WAS MECHANICALLY DILATED WITH A ¿BOUGIE¿ TYPE DILATOR (7 FRENCH TO 10 FRENCH, WILSON-COOK). THE NASOCYSTIC DRAIN AND PANCREATIC STENT WERE PLACED THROUGH THE DUODENAL PAPILLA. THE DISTAL TIP OF NASOCYSTIC DRAIN WAS DEPLOYED WITHIN THE NECROTIC CAVITY. THIS COMPLAINT WAS OPENED TO CAPTURE THE OFF LABEL USE OF THE NPDS-7 ¿ STENTS WERE INSERTED INTO THE CAVITY OF THE LUMEN FOR COLLECTION WITHIN THE NECROTIC CAVITY. AS PER IFU0107-3 THAT ACCOMPANIES THIS DEVICE " THE NASAL PANCREATIC DRAINAGE SET IS USED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC DUCT THROUGH THE NASAL PASSAGE BY USE IF AN INDWELLING CATHETER. " PATIENT OUTCOME: NO ADVERSE EFFECTS TO THE PATIENT NOTED IN THIS STUDY. PATIENT/EVENT INFO - NOTES: BETWEEN 2001 AND 2016, A TOTAL OF 226 PATIENTS UNDERWENT ENDOSCOPIC TREATMENT OF SYMPTOMATIC WOPN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2506373 NASAL PANCREATIC DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male