BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIFLEX RX PUSHER

    MDR report key: 21028291 · Received December 27, 2024

    Report

    Report Number
    3005099803-2024-06691
    Event Type
    Injury
    Date Received
    December 27, 2024
    Date of Event
    May 1, 1999
    Report Date
    December 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY START DATE OF MAY 1999 IS USED FOR THE ESTIMATED DATE OF EVENT. BLOCK H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: KENJIRO YAMAMOTO; TAKAO ITOI; AKIO KATANUMA; TATSUYA ISHII; EISUKE IWASAKI; SHINTARO KAWASAKI; TAKAYOSHI TSUCHIYA; RYOSUKE TONOZUKA; KAZUMASA NAGAI; SHUNTARO MUKAI. "MULTICENTER COMPARATIVE STUDY ON THE USEFULNESS OF THE OPTIMAL ELECTROSURGICAL UNIT SETTING IN ENDOSCOPIC PAPILLECTOMY FOR AMPULLARY NEOPLASMS." JAPANESE SOCIETY OF HEPATO-BILIARY-PANCREATIC SURGERY, J HEPATOBILIARY PANCREAT SCI. 2024; 31:503-511. BLOCK H6: IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF "SEVERE PERFORATION." IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF "MILD TO SEVERE PANCREATITIS." IMDRF PATIENT CODE E2337 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF "MODERATE AND SEVERE PANCREATIC DUCT STENOSIS." IMDRF IMPACT CODE F12 CAPTURES THE ADVERSE EVENTS REPORTED. IMDRF IMPACT CODE F2203 CAPTURES THE IMAGING PERFORMED.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING ADVANIX PANCREATIC STENTS THROUGH THE ARTICLE: "MULTICENTER COMPARATIVE STUDY ON THE USEFULNESS OF THE OPTIMAL ELECTROSURGICAL UNIT SETTING IN ENDOSCOPIC PAPILLECTOMY FOR AMPULLARY NEOPLASMS," BY TAKAO ITOI, ET AL. PER THE ARTICLE, A MULTICENTER, RETROSPECTIVE, COMPARATIVE COHORT STUDY EXAMINED PATIENTS WITH AMPULLARY NEOPLASMS WHO UNDERWENT ENDOSCOPIC PAPILLECTOMY (EP) BETWEEN MAY 1999 AND MARCH 2023. AMONG THE PATIENTS USING THE ADVANIX PANCREATIC STENTS, THE FOLLOWING OUTCOMES WERE REPORTED: SEVERE PERFORATION, MILD TO SEVERE ACUTE PANCREATITIS, AND MODERATE AND SEVERE PANCREATIC DUCT STENOSIS. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS AND FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745398 NAVIFLEX RX PUSHER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION UNK-P-ADVANIX_PANCREATIC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other