BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    MDR report key: 20253204 · Received September 19, 2024

    Report

    Report Number
    3001845648-2024-00512
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    July 12, 2019
    Report Date
    December 23, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    KNS
    PMA / PMN Number
    K022595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, "MULTIVARIATE ANALYSIS OF THE FACTORS AFFECTING THE PROGNOSIS OF WALLED OF PANCREATIC NECROSIS AFTER ENDOSCOPIC ULTRASOUND GUIDED DRAINAGE". THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. ABNORMAL USE COMPLAINTS ARE CONSIDERED TO BE BEYOND ANY FURTHER REASONABLE MEANS OF INTERFACE-RELATED RISK CONTROL BY THE MANUFACTURER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. IT SHOULD BE NOTED THAT THIS FILE IS RELATED TO ANOTHER COMPLAINTS FILE. FOR DETAILS OF THE OTHER INVESTIGATION PLEASE REFER TO (B)(4). MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL CST-10 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. AS THE LOT NUMBER IS UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. INSTRUCTIONS FOR USE AND/LABEL: AS PER THE INSTRUCTIONS FOR USE, IFU0005 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¿. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0005). IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE ABNORMAL USE OF THE DEVICE. FROM THE INFORMATION AVAILABLE, CST DEVICE WAS BEING USED IN A PROCEDURE TO PUNCTURE WOPN, AND ONLY PART B OF THE CST DEVICE WAS USED THIS WAS CONFIRMED BY OUR MEDICAL ADVISOR AS ABNORMAL USE. AS PREVIOUSLY MENTIONED, THE IFU (IFU0005) STATES "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" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED IN THE INTENDED USE.¿ THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, NO HEALTH CONSEQUENCES OR IMPACT REPORTED IN THE STUDY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE OF ABNORMAL USE WAS DETERMINED FROM THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    GUO, 2019 ¿ MULTIVARIATE ANALYSIS OF THE FACTORS AFFECTING THE PROGNOSIS OF WALLED-OFF PANCREATIC NECROSIS AFTER ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE PLASTIC STENTS WERE USED IN 61 PATIENTS (71.8%), OF WHOM 14 RECEIVED 2 OR MORE STENTS. EUS-GUIDED DRAINAGE WITH PLASTIC STENTS FOR PLASTIC STENT DELIVERY, A 19-G NEEDLE (EUS N-19-T; WILSON-COOK MEDICAL, WINSTON-SALEM, NC) WAS USED FOR PUNCTURE. AFTER WITHDRAWING THE INNER NEEDLE STYLET, SOME FLUID WAS ASPIRATED FOR ROUTINE CYTOLOGICAL, BIOCHEMICAL, AND MICROBIOLOGICAL ANALYSIS AND CULTURE. A 0.035-INCH GUIDEWIRE (JAGWIRE; BOSTON-SCIENTIFIC, NATICK, MA) WAS INSERTED THROUGH THE NEEDLE LUMEN INTO THE CYST. SUBSEQUENTLY, A CYSTOTOME (10 FR; WILSON-COOK MEDICAL) WAS USED TO DILATE THE TRACT AND CREATE A LARGE FISTULA. AN EXPANDING BALLOON CATHETER (8¿10 MM IN DIAMETER) WAS OCCASIONALLY USED TO EXPAND THE FISTULA. WE INSERTED 1¿3 DOUBLE-PIGTAIL (DP) PLASTIC STENTS, 7¿10 FR IN DIAMETER AND 3¿9 CM IN LENGTH (7, 8.5 OR 10 FR; ENDO-FLEX GMBH, VOERDE, GERMANY), ALONG THE GUIDEWIRE. IN SOME PATIENTS, A NASOCYSTIC DRAINAGE TUBE (7 FR; WILSON-COOK MEDICAL) WAS USED FOR POSTOPERATIVE WASHING OF THE CYST CAVITY. METAL STENT WAS USED IN 24 PATIENTS (28.2%), INCLUDING DOUBLE-FLARED STENTS IN 18, STRAIGHT STENTS IN 3, AND DOUBLE-FLARED STENTS WITH PLASTIC STENTS IN 3. EUS-GUIDED DRAINAGE WITH METAL STENTS FOR METAL STENT DELIVERY, A 19-G NEEDLE (EUS N-19-T; WILSON-COOK MEDICAL) WAS USED FOR PUNCTURE, A SMALL AMOUNT OF CYST FLUID WAS WITHDRAWN FOR EXAMINATION, AND AN INDWELLING GUIDEWIRE WAS PLACED. A 10-FR CYSTOTOME (WILSON-COOK MEDICAL) WAS INSERTED ALONG THE GUIDEWIRE, A STOMACH/DUODENUM-CYST FISTULA WAS CREATED, AND A METAL STENT (10¿16 MM IN DIAMETER) WAS INTRODUCED OVER THE GUIDEWIRE, WHICH INCLUDED A FULLY COVERED SELF-EXPANDING METAL STENT (BOSTON-SCIENTIFIC, NATICK, MA) OR A LUMEN-APPOSING COVERED SELF-EXPANDING METAL STENT (10 MM IN DIAMETER; MICRO TECHNIQUE, NANJING, CHINA). EUS-GUIDED DRAINAGE WITH A DOUBLE-FANGED FULLY COVERED METAL STENT WITH ELECTROCAUTERY BEFORE THE DELIVERY OF A DOUBLE-FANGED FULLY COVERED METAL STENT WITH ELECTROCAUTERY (10 MM IN DIAMETER; MICRO TECHNIQUE, NANJING, CHINA), A LINEAR ARRAY ECHOENDOSCOPE WAS USED TO EXAMINE THE WOPN. THE COLOR DOPPLER FUNCTION WAS UTILIZED TO DETERMINE WHETHER THE PUNCTURE SITE CONTAINED BLOOD VESSELS. A DOUBLE-FANGED FULLY COVERED METAL STENT WITH ELECTROCAUTERY WAS USED TO CONSTRUCT A FISTULA AND INSERT THE STENT. A NASOCYSTIC DRAINAGE TUBE (7 FR; WILSON-COOK MEDICAL) WAS SOMETIMES USED FOR PFC CAVITY LAVAGE. THIS COMPLAINT WAS OPENED TO CAPTURE 78 OUT OF 85 PATIENTS WHO EXPERIENCED OFF LABEL USE WITH A CST-10. NO INFORMATION ON PATIENT OUTCOME. A TOTAL OF 85 PATIENTS (MALE/FEMALE, 50/35)

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 23-DEC-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532050 CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC KNS COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male