BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    MDR report key: 12357926 · Received August 24, 2021

    Report

    Report Number
    3001845648-2021-00619
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    June 28, 2016
    Report Date
    September 8, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: 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 JOURNAL ARTICLE. "GUO ¿ 2016 .¿ COMPLAINT FILES EMDR 3001845648-2021-00542 AND EMDR 3001845648-2021-00619 WERE OPENED AS A RESULT OF THIS PAPER. THESE FILES WERE OPENED FOR THE FOLLOWING REASONS; EMDR 3001845648-2021-00542 - ¿OFF LABEL USE OF EVO-FC-B AND STENT OCCLUSION.¿ EMDR 3001845648-2021-00619 - ¿OFF LABEL USE OF CST-10¿ (WHICH THIS FILE WILL INVESTIGATE). DOCUMENTS REVIEW INCLUDING IFU REVIEW: 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, IFU0005-11 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 IT WAS NOT USED IN A PANCREATIC PSEUDOCYST. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO OFF LABEL USE AS IT WAS NOT USED IN A PANCREATIC PSEUDOCYST . SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    FINAL MDR BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 08-SEPT-2021.

    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

    GUO ET AL 2016 (CST-10, EVO-FC-B) ¿ ¿ENDOSCOPIC ULTRASOUND-GUIDED BILIARY DRAINAGE USING A FULLY COVERED METALLIC STENT AFTER FAILED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY¿. EQUIPMENT: 19-GAUGE NEEDLE (EUS N-19-T; WILSON-COOK MEDICAL, WINSTON-SALEM, NC, USA) WAS USED FOR PUNCTURE. A 0.035-INCH GUIDEWIRE (JAGWIRE; BOSTON-SCIENTIFIC, NATICK, MA, USA) WAS USED FOR GUIDANCE. A CYSTOTOME (10 FR; WILSON-COOK MEDICAL) WAS USED TO DILATE THE TRACT AND CREATE A LARGE FISTULA. A FULLY COVERED METALLIC STENT (WILSON-COOK MEDICAL, WINSTON-SALEM, NC, USA) WAS USED FOR BILIARY DRAINAGE. PROPHYLACTIC INTRAVENOUS ANTIBIOTICS (CEFTRIAXONE, 1 G) WERE ADMINISTERED ROUTINELY TWICE DAILY FOR AT LEAST 2 DAYS AFTER THE PROCEDURE. EUS-GUIDED HGS (EUS-HGS): SEVEN PATIENTS UNDERWENT HGS. AFTER CHECKING THE LOCAL VASCULATURE BY COLOR DOPPLER, THE 19 G EUS PUNCTURE NEEDLE WAS THEN ADVANCED INTO THE INTRAHEPATIC DUCT AND CHOLANGIOGRAPHY WAS PERFORMED, WHICH USUALLY DELINEATED THE DILATED BILIARY TREE DOWN TO THE POINT OF OBSTRUCTION. A GUIDEWIRE WAS THEN INSERTED THROUGH THE NEEDLE AND A CYSTOTOME WAS USED TO CREATE A FISTULA BETWEEN THE STOMACH (OR JEJUNUM IN PATIENTS WITH TOTAL GASTRECTOMY) AND THE LEFT HEPATIC DUCT. ONCE THE FISTULA HAD BEEN DILATED, A FULLY COVERED SELF-EXPANDABLE METAL STENT (SEMS) (8¿10 DIAMETER × 4¿10 CM LONG, FULLY COVERED WITH A SILICON MEMBRANE) WAS INSERTED AND DEPLOYED TRANSMURALLY. TO AVOID BILE LEAKAGE INTO THE PERITONEUM, A 7 FR NASOBILIARY CATHETER WAS SOMETIMES PLACED THROUGH THE METALLIC STENT FOR 48 H. SOMETIMES AN UNCOVERED SEMS WAS PLACED THROUGH THE COVERED STENT TO AVOID STENT MIGRATION. EUS-GUIDED CDS (EUS-CDS): 14 PATIENTS UNDERWENT CDS. FOR CDS, THE NEEDLE WAS DIRECTED TOWARDS THE HILAR (PROXIMAL) BILE DUCT BY MAINTAINING A LONG SCOPE POSITION, USUALLY FROM THE DUODENAL BULB. THIS WAS IMPORTANT BECAUSE AN UPWARD NEEDLE ORIENTATION FACILITATED THE PROCEDURE BY DECREASING THE ANGLE FOR TRANSMURAL STENT ADVANCEMENT INTO THE BILE DUCT. AFTER PLACEMENT OF A GUIDEWIRE, A FISTULA WAS CREATED USING A CYSTOTOME, TO PASS THE STENT INTO THE BILE DUCT. ONCE THE FISTULA WAS DILATED, AN SEMS (FULLY COVERED) WAS INSERTED AND DEPLOYED TRANSMURALLY. OFF LABEL USE: CST-10 USED TO DILATE THE TRACT AND CREATE A LARGE FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256450 CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC KNS COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR