BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    MDR report key: 19982750 · Received August 14, 2024

    Report

    Report Number
    3001845648-2024-00471
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    October 17, 2022
    Report Date
    August 14, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    KNS
    PMA / PMN Number
    K022595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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

    CANCELLATION REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 14-AUG-2024. INITIAL MDR REPORT GENERATED AND SUBMITTED IN ERROR. CANCELLATION REPORT SCHEDULED FOR SUBMISSION AS THE REPORT HAS BEEN SUBMITTED UNDER PR (B)(4).

    Description of Event or Problem · 0

    (B)(4) 2022 ¿ EFFICACY AND SAFETY OF ENDOSCOPIC DRAINAGE OF PERIPANCREATIC FLUID COLLECTIONS: A RETROSPECTIVE MULTICENTER EUROPEAN STUDY THIS INTERNATIONAL, MULTICENTER, RETROSPECTIVE COHORT STUDY INVOLVED 10 EUROPEAN TERTIARY HOSPITALS ACROSS 4 EUROPEAN COUNTRIES: ATHENS, GREECE (5 CENTERS); MILAN/FOGGIA/VERONA, ITALY; AND ZAGREB, CROATIA AND BUDAPEST, HUNGARY. PFC DRAINAGE WITH DPPS THE PFC WAS DIRECTLY PUNCTURED USING A 10-FR CYSTOTOME (CYSTOTOME TM, COOK MEDICAL, WINSTON SALEM, NC, USA; OR THE CYSTO-GASTRO-SET RU, ENDO-FLEX GMBH, VOERDE, NIEDERRHEIN, NORDRHEIN-WESTFALEN, GERMANY) UNDER ULTRASOUND AND FLUOROSCOPIC GUIDANCE. ONE OR 2 GUIDEWIRES WERE THEN PUSHED INTO THE CAVITY THROUGH THE CYSTOTOME AND PNEUMATIC DILATION OF THE FISTULA WAS PERFORMED USING A 6- OR 8-MM BALLOON (MAXFORCE, BOSTON SCIENTIFIC) AND 1 OR 2 DPPS (3 CM LENGTH, 7 OR 10 FR DIAMETER) DEPLOYED INTO THE PFC. DPPS WERE REMOVED WHEN CLINICAL SUCCESS OF DRAINAGE WAS ACHIEVED. AS PER THE INTENDED USE OF THE CST-10, THE DEVICE IS USED 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. THIS FILE WILL CAPTURE OFF LABEL USE OF THE CST-10 DEVICE FOR THE PUNCTURING OF A WALLED OFF PANCREATIC NECROSIS (WON), POTENTIALLY OCCURRING IN CROATIA. NO ADVERSE EFFECTS REPORTED AS OCCURRING. MEAN AGE 57.2±11.9 YEARS, 71.9% MALE.

    Description of Event or Problem · 0

    CANCELLATION REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 14-AUG-2024. INITIAL MDR REPORT GENERATED AND SUBMITTED IN ERROR. CANCELLATION REPORT SCHEDULED FOR SUBMISSION AS THE REPORT HAS BEEN SUBMITTED UNDER PR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517487 CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC KNS COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male