BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROKNIFE XL

    MDR report key: 17741225 · Received September 13, 2023

    Report

    Report Number
    3005099803-2023-04931
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    November 1, 2011
    Report Date
    September 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2, A3: PATIENTS EXACT AGES AND SEXES ARE UNKNOWN. HOWEVER, THE MEAN AGE OF PATIENTS IN THE STUDY WAS 60.4 YEARS AND 257 (47.5%) PATIENTS WERE MALE. BLOCK B3: ACCORDING TO THE LITERATURE ARTICLE, PROCEDURES WERE PERFORMED BETWEEN (B)(6) 2011 AND (B)(6) 2014. BLOCK D4, H4: THE DEVICE UPNS OR LOT NUMBERS WERE NOT PROVIDED IN THE LITERATURE ARTICLE. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. ADDITIONAL INITIAL REPORTER EMAIL: (B)(6). BLOCK G2: LITERATURE SOURCE: JOURNAL ARTICLE: (B)(6), ET AL. "SUPRAPAPILLARY NEEDLE KNIFE FISTULOTOMY VERSUS CONVENTIONAL PRECUT SPHINCTEROTOMY IN DIFFICULT BILIARY CANNULATION: A RETROSPECTIVE COMPARATIVE STUDY." SURG LAPAROSC ENDOSC PERCUTAN TECH; VOLUME 32, NUMBER 6, DECEMBER 2022. BLOCK H6: IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE, MAJOR.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AUTOTOME SPHINCTEROTOME AND NEEDLE KNIFE SPHINCTEROTOME DEVICES THROUGH THE ARTICLE, SUPRAPAPILLARY NEEDLE KNIFE FISTULOTOMY VERSUS CONVENTIONAL PRECUT SPHINCTEROTOMY IN DIFFICULT BILIARY CANNULATION: A RETROSPECTIVE COMPARATIVE STUDY, BY (B)(6), MD, ET AL. PER THE ARTICLE, THE STUDY WAS DESIGNED AS A RETROSPECTIVE COMPARATIVE COHORT STUDY CONDUCTED FROM A SINGLE MEDICAL CENTER AND INCLUDED PROCEDURES THAT WERE PERFORMED BETWEEN (B)(6) 2011 AND (B)(6) 2014. THREE BILIARY CANNULATION METHODS WERE PERFORMED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND EVALUATED FOR EFFECTIVENESS AND SAFETY IN THE STUDY: STANDARD CANNULATION WITH A GUIDEWIRE LOADED PULL-TYPE SPHINCTEROTOME WITHOUT CONTRACT ASSISTANCE, NEEDLE KNIFE FISTULOTOMY (NKF), AND CONVENTIONAL PRECUT SPHINCTEROTOMY (CPS). ANALYSES WERE PERFORMED WITH 541 PATIENTS WITH THE MEAN AGE OF 60.4 YEARS, AND 257 (47.5%) PATIENTS WERE MALE. ALL PROCEDURES WERE PERFORMED BY A SINGLE EXPERIENCED ENDOSCOPIST, AND CANNULATION WAS CONSIDERED DIFFICULT IF IT COULD NOT BE ACHIEVED WITH THE STANDARD CANNULATION METHOD WITHIN 5 MINUTES OR DESPITE FIVE ATTEMPTS OR IF THE GUIDEWIRE WAS UNINTENTIONALLY INSERTED INTO THE PANCREATIC DUCT 5 TIMES. WHILE STANDARD CANNULATION WAS SUCCESSFUL IN 366 (67.6%), DIFFICULT BILIARY CANNULATION WAS OBSERVED IN 175 (32.4%) PATIENTS. A 5MM NEEDLE LENGTH NEED KNIFE SPHINCTEROTOME WAS USED FOR NKF. NKF WAS PERFORMED IN 101 (57.7%) PATIENTS, AND CANNULATION SUCCESS WAS 100% IN THE FIRST ERCP SESSION. A 5MM NEEDLE LENGTH NEED KNIFE SPHINCTEROTOME OR A GUIDEWIRE LOADED PULL-TYPE SPHINCTEROTOME WAS USED FOR CPS. CPS WAS PERFORMED IN 74 (42.3%) PATIENTS WITH A LOWER CANNULATION SUCCESS RATE (79.7%) THAN NKF. NKF WAS FOUND TO HAVE HIGH BILIARY CANNULATION SUCCESS AND LOW POST-ERCP PANCREATITIS (PEP) RISK. USING THE CONVENTIONAL PRECUT SPHINCTEROTOMY (CPS) METHOD, POST-ERCP PANCREATITIS (PEP) WAS OBSERVED IN 7 PATIENTS, MAJOR BLEEDING WAS OBSERVED IN 3 PATIENTS AND POST-ERCP CHOLANGITIS WAS OBSERVED IN 1 PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109285 MICROKNIFE XL UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other