BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROKNIFE XL

    MDR report key: 23697904 · Received December 2, 2025

    Report

    Report Number
    3005099803-2025-06332
    Event Type
    Death
    Date Received
    December 2, 2025
    Date of Event
    January 1, 2013
    Report Date
    December 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B2: THE EXACT DATE OF THE PATIENTS' DEATH WAS NOT REPORTED. THE RETROSPECTIVE STUDY START DATE OF (B)(6) 2013, IS USED FOR THE ESTIMATED DATE OF DEATH. BLOCK B3: THE EXACT DATE OF THE EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE OF (B)(6) 2013, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN JANUARY 2013 AND DECEMBER 2023. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WERE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE SOURCE: WAI LIAM LAM; MICHAEL DING; CHIA CHUIN YAU; RODERICK PRAWIRADIRADJA; SRISHA HEBBAR. "EARLY AND PRIMARY NEEDLE KNIFE FISTULOTOMY IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP): SHOULD THIS BE USED MORE OFTEN?" GASTROENTEROLOGY, UNIVERSITY HOSPITALS OF NORTH MIDLANDS NHS TRUST, STOKE-ON-TRENT, UK, FRONTLINE GASTROENTEROLOGY 2025;0:1-7, HTTPS:// DOI.ORG/ 10. 1136/ FLGASTRO- 2024-102937. BLOCK H6: IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF IMPACT CODE F02 CAPTURES THE PATIENT'S DEATH.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT INVOLVING A RX NEEDLE KNIFE XL AND DREAMWIRE THROUGH THE ARTICLE TITLED, "EARLY AND PRIMARY NEEDLE KNIFE FISTULOTOMY IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP): SHOULD THIS BE USED MORE OFTEN?", BY WAI LIAM LAM ET AL. PER THE ARTICLE, BETWEEN JANUARY 2013 AND DECEMBER 2023, A TOTAL OF 329 PATIENTS UNDERWENT NEEDLE KNIFE FISTULOTOMY IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR BILIARY ACCESS. ONE PATIENT EXPERIENCED SEVERE PANCREATITIS WHICH RESULTED TO DEATH. PLEASE SEE THE REFERENCE ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2850612 MICROKNIFE XL UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death