BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE REVOLUTION

    MDR report key: 25263553 · Received May 23, 2026

    Report

    Report Number
    3005099803-2026-02048
    Event Type
    Injury
    Date Received
    May 23, 2026
    Date of Event
    January 1, 2010
    Report Date
    May 22, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE OF JANUARY 1, 2010, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN JANUARY 1, 2010, AND JANUARY 1, 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 E1: INITIAL REPORTER CITY: CLERMONT-FERRAND, AUVERGNE-RHONE-ALPES; REPORTED HERE AS THE ADDRESS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G2: LITERATURE SOURCE: THOMAS GUILMOTEAU, ET AL. DIRECT COMPARISON OF SIMULTANEOUS AND SEQUENTIAL ENDOSCOPIC METALLIC BILATERAL STENTING IN MALIGNANT HILAR BILIARY OBSTRUCTION. WORLD J GASTROENTEROL 2025 MAY 21; 31(19): 101913. DOI: 10.3748/WJG. V31.I19.101913 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/BLOOD LOSS/BLEEDING. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO A JAGWIRE REVOLUTION AND HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING A JAGWIRE REVOLUTION AND HURRICANE RX DILATATION BALLOON THROUGH THE ARTICLE "DIRECT COMPARISON OF SIMULTANEOUS AND SEQUENTIAL ENDOSCOPIC METALLIC BILATERAL STENTING IN MALIGNANT HILAR BILIARY OBSTRUCTION" BY THOMAS GUILMOTEAU, ET AL. THIS RETROSPECTIVE STUDY FOCUSED ON THE DIFFERENT DRAINAGE TECHNIQUES USING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR MALIGNANT HILAR BILIARY OBSTRUCTION. ALL PATIENTS WHO UNDERWENT BILATERAL BILIARY METALLIC STENTING DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR MHBO IN CLERMONT-FERRAND UNIVERSITY HOSPITAL BETWEEN JANUARY 1, 2010, AND JANUARY 1, 2023. CONVENTIONAL SEQUENTIAL SBS PLACEMENT WAS PERFORMED AT OUR INSTITUTION BETWEEN 2010 AND 2017. SINCE 2017, SIMULTANEOUS SBS PLACEMENT HAS BEEN PERFORMED ON PATIENTS WITH UNRESECTABLE MHBOS REQUIRING BILATERAL DRAINAGE. THE PATIENT COHORT WAS DIVIDED INTO THOSE WHO UNDERWENT SEQUENTIAL SBS OR SIS PLACEMENT BETWEEN 2010 AND 2017 (SEQUENTIAL GROUP) AND THOSE WHO UNDERWENT SIMULTANEOUS SBS PLACEMENT BETWEEN 2017 AND 2023 (SIMULTANEOUS GROUP). THE TWO GROUPS WERE COMPARED RETROSPECTIVELY. THE ARTICLE REPORTED PROCEDURAL DETAILS AND OUTCOMES FOLLOWING THE SIMULTANEOUS SBS TECHNIQUE. ADVERSE EVENTS INCLUDED PANCREATITIS IN 5 PATIENTS (NO INTENSIVE CARE UNIT ADMISSION OR ENDOSCOPIC/SURGICAL INTERVENTION REQUIRED), CHOLANGITIS IN 4 PATIENTS (TWO REQUIRING INTENSIVE CARE UNIT ADMISSION), MEDICALLY MANAGED HEMORRHAGE IN FOUR PATIENTS, AND RECURRENT BILIARY OBSTRUCTION IN THIRTEEN PATIENTS. PLEASE REFER TO THE REFERENCED ARTICLE FOR FULL DETAILS, DATA ANALYSIS, AND LIST OF PARTICIPATING INVESTIGATORS AND INSTITUTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561092 JAGWIRE REVOLUTION ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R