BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    MDR report key: 10617489 · Received October 1, 2020

    Report

    Report Number
    3001845648-2020-00703
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    November 15, 2013
    Report Date
    February 23, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    KNS
    PMA / PMN Number
    K022595
    Adverse Event
    Yes
    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. THE CST-10 DEVICES OF UNKNOWN LOT NUMBERS INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. REFERENCE "SMOCZYNSKI 2014 - ENDOSCOPIC DRAINAGE/DEBRIDEMENT OF WALLED-OFF PANCREATIC NECROSIS¿ THIS FILE WAS OPENED TO INVESTIGATE 4 CASES OF GASTROINTESTINAL TRACT PERFORATION IN RELATION TO CST-10 WHICH WAS USED OFF LABEL USE. PLEASE NOTE THAT WORSE CASE F19 CODE (SURGICAL INTERVENTION) IS BEING APPLIED FOR ALL EVEN THOUGH THE INFORMATION INDICATES THAT ONLY 2 PATIENTS REQUIRED SURGICAL INTERVENTION. PRIOR TO DISTRIBUTION, ALL CST-10 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS THE LOT NUMBERS ARE UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. AS PER THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES THIS DEVICE, INSTRUCTS THE USER " THE DEVICE IS DESIGNED TO ELECTROSURGICALLY PUNCTURE A HOLE IN THE TRANSGASTRIC OR TRANSDUODENAL WALL AND INTO A PANCREATIC PSEUDOCYST, WHEN IT IS VISIBLY BULGING INTO THE GASTROINTESTINAL TRACT¿. IT MAY BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, AS PUNCTURING WON (WALLED-OFF NECROSIS) WITH CST-10 DEVICE IS CONSIDERED OFF LABEL USE. A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO OFF LABEL USE AS PUNCTURING WON (WALLED-OFF NECROSIS) WITH CST-10 DEVICE IS CONSIDERED OFF LABEL USE AS PER INPUT FROM MEDICAL AFFAIRS ¿CST DEVICE BEING USED PUNCTURE WON IS OFF-LABEL USE¿. COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, PERFORATION OF THE GASTROINTESTINAL TRACT WALL OCCURRED IN FOUR PATIENTS - TWO WERE TREATED CONSERVATIVELY, TWO SURGICALLY. IN BOTH PATIENTS THE STOMA WAS MADE WITH THE GIOVANNINI CYSTOTOME AND DILATATION WAS NOT PERFORMED. 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 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS. 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 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. PERFORATION OF THE GASTROINTESTINAL TRACT WALL OCCURRED IN FOUR PATIENTS - TWO WERE TREATED CONSERVATIVELY, TWO SURGICALLY. IN BOTH PATIENTS THE STOMA WAS MADE WITH THE GIOVANNINI CYSTOTOME AND DILATATION WAS NOT PERFORMED. THIS FILE IS CAPTURING THE 4 CASES OF GASTROINTESTINAL TRACT PERFORATION IN RELATION TO CST-10. IT CAN BE NOTED THAT THIS DEVICE WAS ALSO USED OFF-LABEL. CST DEVICE USED TO PUNCTURE WON(WALLED-OFF NECROSIS) IS OFF-LABEL USE. A SEPARATE COMPLAINT HAS BEEN CREATED TO CAPTURE THE GENERAL OFF LABEL OF CST-10 - REFERENCE MDR#3001845648-2020-00702.

    Additional Manufacturer Narrative · 1

    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. PERFORATION OF THE GASTROINTESTINAL TRACT WALL OCCURRED IN FOUR PATIENTS - TWO WERE TREATED CONSERVATIVELY, TWO SURGICALLY. IN BOTH PATIENTS THE STOMA WAS MADE WITH THE GIOVANNINI CYSTOTOME AND DILATATION WAS NOT PERFORMED. THIS FILE IS CAPTURING THE 4 CASES OF GASTROINTESTINAL TRACT PERFORATION IN RELATION TO CST-10. IT CAN BE NOTED THAT THIS DEVICE WAS ALSO USED OFF-LABEL. CST DEVICE USED TO PUNCTURE WON(WALLED-OFF NECROSIS) IS OFF-LABEL USE. A SEPARATE COMPLAINT HAS BEEN CREATED TO CAPTURE THE GENERAL OFF LABEL OF CST-10 (108 PATIENTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077666 CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC KNS COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention