BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL PANCREATIC DRAINAGE SET

    MDR report key: 10620910 · Received October 2, 2020

    Report

    Report Number
    3001845648-2020-00707
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Date of Event
    November 15, 2013
    Report Date
    February 25, 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

    COMPONENT CODE (ANNEX G): G07001 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PMA/510(K) #: K171623. THE NPDS 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. AS THE LOT NUMBER OF THE COMPLAINT STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION NPDS DEVICES ARE SUBJECTED TO 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 STATES THE FOLLOWING: ¿THE NASAL PANCREATIC DRAINAGE SET IS USED FOR TEMPORARY DRAINAGE OF THE PANCREATIC DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER.¿ AND IN THE PRECAUTIONS SECTION ¿THIS DEVICE IS NOT INTENDED FOR USE BEYOND 29 DAYS¿ AS MENTIONED IN THE ARTICLE A ¿FISTULA WAS PERFORMED ON THE TOP OF THE LARGEST BULGE INTO THE GASTRIC OR DUODENAL WALL¿ AND ¿THROUGH THE FISTULA DRAINAGE SYSTEM WAS INSTALLED CONSISTING OF 10 FR ¿DOUBLE PIGTAIL¿ ENDOPROSTHESES (ZSO-10-5, WILSON COOK) AND 7 FR OR 8.5 FR NASOCYSTIC DRAINS (BALTON OR WILSON- COOK).¿ AS PER CLINICAL INPUT ALL DEVICES IN THE FISTULA/ PANCREATIC DRAINAGE SYSTEM WERE USED TRANSMURALLY, TRANSGASTRIC OR PERCUTANEOUSLY AND WERE THEREFORE USED OFF LABEL. THE POTENTIAL USER ERROR OF THE STENT EXCEEDING THE 29-DAY USE PERIOD WAS ALSO NOTED. AS PER ARTICLE ¿TRANSMURAL ENDOPROSTHESES WERE MAINTAINED FOR AN AVERAGE OF 8 MONTHS (1-24)¿ IT WAS NOTED THAT IN 6 OF THE INITIAL 112 PATIENTS ENDOSCOPIC PANCREATOGRAPHY WAS NOT ACHIEVABLE AS THE DUODENUM WAS INACCESSIBLE BECAUSE OF COMPRESSION ON GI TRACT, A FURTHER 8 PATIENTS DID NOT COMPLETE THE PROCEDURE DUE TO MASSIVE BLEEDING FOLLOWING THE EXECUTION OF THE STOMA OPENING, STOMACH PERFORATION, SEPSIS, COLLECTION PERFORATION, AND DEATH. 18 PATENTS ALSO EXPERIENCED STOMA BLEEDING. THESE HAVE ALL BEEN DISASSOCIATED FROM OUR DEVICES BY CLINICAL INPUT. PERFORATION OF THE GASTROINTESTINAL TRACT WALL OCCURRED IN FOUR PATIENTS AND WAS RELATED TO THE CST-10 DEVICE. A SECONDARY INFECTION NOTED IN 38 PATIENTS HAS BEEN ATTRIBUTED TO THE PATIENT¿S UNDERLYING CONDITION AND WAS NOT RELATED TO ONE OF OUR DEVICES A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS USED OUTSIDE ITS STATED INTENDED USE IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. THE DEVICE WAS USED OFF-LABEL AS IT WAS PLACED TRANSGASTRIC/TRANSDUODENALLY THROUGH A FISTULA INTO WALLED-OFF NECROSIS FOR FLUID COLLECTION, SECONDARY TO OFF-LABEL USE WAS USER ERROR OF INDWELL PERIOD EXCEEDING 29 DAYS. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. LONG TERM SUCCESS WAS ACHIEVED IN 94 OF THE 112 PATIENTS, NO ADDITIONAL ADVERSE EVENTS WERE REPORTED TO THE PATIENT AS A RESULT OF DEVICE USE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON10-MAR-2021 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS. IT CAN BE NOTED ON FURTHER REVIEW OF THIS PAPER AND RECEIPT OF CLINICAL INPUT ON (B)(6) 2021 THE DESCRIPTION OF EVENT HAS BEEN UPDATED. UPDATED DESCRIPTION: "TO ALSO COVER POTENTIAL FOR USER ERROR AS TRANSMURAL ENDOPROSTHESES WERE MAINTAINED FOR AN AVERAGE OF 8 MONTHS (1- 24)." INITIAL REPORT DETAILS: SMOCYNSKI 2013 ¿ENDOSCOPIC DRAINAGE/DEBRIDEMENT OF WALLED-OFF PANCREATIC NECROSIS - SINGLE CENTER EXPERIENCE OF 112 CASES¿ BETWEEN 2001 AND 2011 IN THE DEPARTMENT OF GASTROENTEROLOGY AND HEPATOLOGY OF THE (B)(6) 112 PATIENTS WITH WON UNDERWENT ENDOSCOPIC TREATMENT. THE MAIN PANCREATIC DUCT LEAK WAS OBSERVED IN 81 PATIENTS, THEN PANCREATIC SPHINCTEROTOMY WAS PERFORMED WITH THE USE OF OLYMPUS FLOWCUT KD-301Q0725 SPHINCTROTOME AND A 5-10 FR PANCREATIC ENDOPROSTHESIS (GEENEN OR ZIMMON PANCREATIC STENT, WILSON-COOK MEDICALINC.) WAS INTRODUCED INTO THE MAIN PANCREATIC DUCT. FISTULA WAS PERFORMED ON THE TOP OF THE LARGEST BULGE INTO THE GASTRIC OR DUODENAL WALL. WHEN THE BULGING WAS NOT VISIBLE THE FOLLOWING GUIDELINES WERE USED: TOPOGRAPHIC DATA OBTAINED FROM CECT, FLUOROSCOPIC IMAGE OF THE MAIN PANCREATIC DUCT LEAK OR THE FLOW OF CONTRAST MEDIUM ADMINISTERED THROUGH PERCUTANEOUS DRAIN AND OPACIFICATION OF THE COLLECTION WITH CONTRAST. THE ENTEROSTOMY WAS PERFORMED WITH A 7 FR FISTULOTOME (HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE HPC-3, WILSON-COOK) OR A GIOVANNINI CYSTOTOME (CYSTOTOME CST-10, WILSON-COOK). THE FLUID SAMPLE WAS OBTAINED FROM THE COLLECTION TO ASSESS AMYLASE ACTIVITY AND MICROBIAL CULTURING. THE MORPHOLOGY OF THE ASPIRATE E DARK AND VISIBLE NECROTIC DEBRIS WAS USED AS NECROSIS INDICATOR. THE STOMA WAS WIDENED WITH THE USE OF ¿BOUGIE¿ TYPE CATHETERS (SOEHENDRA BILIARY DILATION CATHETERS SBDC-8.5, SBDC-10, WILSON-COOK) ALONE IN 60 PATIENTS AND WITH HIGH-PRESSURE BALLOONS OF 8 OR 20 MM IN DIAMETER (BOSTON SCIENTIFIC) - IN 33 PATIENTS (8 MM IN 15 PATIENTS AND 20 MM IN 18 PATIENTS). THROUGH THE FISTULA DRAINAGE SYSTEM WAS INSTALLED CONSISTING OF 10 FR ¿DOUBLE PIGTAIL¿ ENDOPROSTHESES (ZSO-10-5, WILSON COOK) AND 7 FR OR 8.5 FR NASOCYSTIC DRAINS (BALTON OR WILSON- COOK). IN THE CASES OF CLINICAL SUSPICION THAT THE SYSTEM DID NOT DRAIN THE WHOLE NECROTIC AREA, THE POSITIONING OF THE DRAIN WAS ALTERED, ANOTHER FISTULA WAS MADE IN A NEW LOCATION, OR THE DRAIN WAS INTRODUCED TRANSPAPILLARILY THROUGH THE MAIN PANCREATIC DUCT LEAK. WON WAS IRRIGATED WITH A VOLUME OF SALINE SOLUTION FITTED TO THE SIZE OF THE COLLECTION (60E200 ML). IN THE FIRST 48 H OF TREATMENT IRRIGATION WAS PERFORMED EVERY 2 H, IN THE SUBSEQUENT 48 H EVERY 4 H. ALL PATIENTS RECEIVED ANTIBIOTICS (CIPROFLOXACIN OR CEFTRIAXONE WITH METRONIDAZOLE) PRIOR TO THE PROCEDURE. ROUTINELY ANTIBIOTIC THERAPY WAS CONTINUED FOR 2 WEEKS.SALINE SOLUTION FITTED TO THE SIZE OF THE COLLECTION (60E200 ML). IN THE FIRST 48 H OF TREATMENT IRRIGATION WAS PERFORMED EVERY 2 H, IN THE SUBSEQUENT 48 H EVERY 4 H. ALL 7 FR OR 8.5 FR NASOCYSTIC DRAINS WERE USED OFF-LABEL. TRANSGASTRIC AND TRANSDUODENAL STENT PLACEMENT THROUGH FISTULA INTO WON FLUID COLLECTIONS OFF-LABEL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SMOCYNSKI 2013, 'ENDOSCOPIC DRAINAGE/DEBRIDEMENT OF WALLED-OFF PANCREATIC NECROSIS - SINGLE CENTER EXPERIENCE OF 112 CASES'. BETWEEN 2001 AND 2011 IN THE DEPARTMENT OF GASTROENTEROLOGY AND HEPATOLOGY OF THE MEDICAL UNIVERSITY OF GDANSK 112 PATIENTS WITH WON UNDERWENT ENDOSCOPIC TREATMENT. THE MAIN PANCREATIC DUCT LEAK WAS OBSERVED IN 81 PATIENTS, THEN PANCREATIC SPHINCTEROTOMY WAS PERFORMED WITH THE USE OF OLYMPUS FLOWCUT KD-301Q0725 SPHINCTROTOME AND A 5-10 FR PANCREATIC ENDOPROSTHESIS (GEENEN OR ZIMMON PANCREATIC STENT, WILSON-COOK MEDICALINC.) WAS INTRODUCED INTO THE MAIN PANCREATIC DUCT. FISTULA WAS PERFORMED ON THE TOP OF THE LARGEST BULGE INTO THE GASTRIC OR DUODENAL WALL. WHEN THE BULGING WAS NOT VISIBLE THE FOLLOWING GUIDELINES WERE USED: TOPOGRAPHIC DATA OBTAINED FROM CECT, FLUOROSCOPIC IMAGE OF THE MAIN PANCREATIC DUCT LEAK OR THE FLOW OF CONTRAST MEDIUM ADMINISTERED THROUGH PERCUTANEOUS DRAIN AND OPACIFICATION OF THE COLLECTION WITH CONTRAST. THE ENTEROSTOMY WAS PERFORMED WITH A 7 FR FISTULOTOME (HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE HPC-3, WILSON-COOK) OR A GIOVANNINI CYSTOTOME (CYSTOTOME CST-10, WILSON-COOK). THE FLUID SAMPLE WAS OBTAINED FROM THE COLLECTION TO ASSESS AMYLASE ACTIVITY AND MICROBIAL CULTURING. THE MORPHOLOGY OF THE ASPIRATE E DARK AND VISIBLE NECROTIC DEBRIS WAS USED AS NECROSIS INDICATOR. THE STOMA WAS WIDENED WITH THE USE OF ¿BOUGIE¿ TYPE CATHETERS (SOEHENDRA BILIARY DILATION CATHETERS SBDC-8.5, SBDC-10, WILSON-COOK) ALONE IN 60 PATIENTS AND WITH HIGH-PRESSURE BALLOONS OF 8 OR 20 MM IN DIAMETER (BOSTON SCIENTIFIC) - IN 33 PATIENTS (8 MM IN 15 PATIENTS AND 20 MM IN 18 PATIENTS). THROUGH THE FISTULA DRAINAGE SYSTEM WAS INSTALLED CONSISTING OF 10 FR ¿DOUBLE PIGTAIL¿ ENDOPROSTHESES (ZSO-10-5, WILSON COOK) AND 7 FR OR 8.5 FR NASOCYSTIC DRAINS (BALTON OR WILSON- COOK). IN THE CASES OF CLINICAL SUSPICION THAT THE SYSTEM DID NOT DRAIN THE WHOLE NECROTIC AREA, THE POSITIONING OF THE DRAIN WAS ALTERED, ANOTHER FISTULA WAS MADE IN A NEW LOCATION, OR THE DRAIN WAS INTRODUCED TRANSPAPILLARILY THROUGH THE MAIN PANCREATIC DUCT LEAK. WON WAS IRRIGATED WITH A VOLUME OF SALINE SOLUTION FITTED TO THE SIZE OF THE COLLECTION (60E200 ML). IN THE FIRST 48 H OF TREATMENT IRRIGATION WAS PERFORMED EVERY 2 H, IN THE SUBSEQUENT 48 H EVERY 4 H. ALL PATIENTS RECEIVED ANTIBIOTICS (CIPROFLOXACIN OR CEFTRIAXONE WITH METRONIDAZOLE) PRIOR TO THE PROCEDURE. ROUTINELY ANTIBIOTIC THERAPY WAS CONTINUED FOR 2 WEEKS.SALINE SOLUTION FITTED TO THE SIZE OF THE COLLECTION (60E200 ML). IN THE FIRST 48 H OF TREATMENT IRRIGATION WAS PERFORMED EVERY 2 H, IN THE SUBSEQUENT 48 H EVERY 4 H. ALL 7 FR OR 8.5 FR NASOCYSTIC DRAINS WERE USED OFF-LABEL. TRANSGASTRIC AND TRANSDUODENAL STENT PLACEMENT THROUGH FISTULA INTO WON FLUID COLLECTIONIS OFF-LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084734 NASAL PANCREATIC DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR