BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX NEEDLE KNIFE XL

    MDR report key: 20679955 · Received November 13, 2024

    Report

    Report Number
    3005099803-2024-05815
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    January 1, 2009
    Report Date
    November 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729283799
    PMA / PMN Number
    K973826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE JANUARY 1, 2009, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN JANUARY 2009 AND DECEMBER 2016. THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL, REPORTED HERE AS THE NAME EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. BLOCK G2: LITERATURE SOURCE JOURNAL ARTICLE: LEE Y, ET AL. "USEFULNESS AND COMPLICATIONS OF NEEDLE KNIFE FISTULOTOMY AS A RESCUE PROCEDURE IN PATIENTS WITH PANCREATICOBILIARY DISEASE" KOREAN J GASTROENTEROL 2020; HTTPS://DOI.ORG/10.4166/KJG.2020.75.6.341 BLOCK H6: IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE. IMDRF PATIENT CODE E2326 CAPTURES THE REPORTABLE EVENT OF INFLAMMATION (HYPERAMYLASEMIA).

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES MENTIONED IN THE LITERATURE ARTICLE. REFER TO MANUFACTURER REPORTS # 3005099803-2024-05813 AND 3005099803-2024-05814 FOR THE ASSOCIATED DEVICE INFORMATION. BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING ULTRATOME XL SPHINCTEROTOMES, FLUORO TIP ERCP CATHETERS, AND NEEDLE KNIFE PAPILLOTOMES, THROUGH THE ARTICLE, USEFULNESS AND COMPLICATIONS OF NEEDLE KNIFE FISTULOTOMY AS A RESCUE PROCEDURE IN PATIENTS WITH PANCREATICOBILIARY DISEASE, BY YONG JAE LEE, ET AL. PER THE ARTICLE, BETWEEN JANUARY 2009 AND DECEMBER 2016, PATIENTS UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, AND THE FOLLOWING OCCURRED: MILD AND MODERATE PANCREATITIS, BLEEDING AND HYPERAMYLASEMIA. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204373 RX NEEDLE KNIFE XL UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00545840 08714729283799

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other