BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX BILIARY

    MDR report key: 17376230 · Received July 24, 2023

    Report

    Report Number
    3005099803-2023-03889
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2023 BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION.

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT WAS APPROXIMATED TO JUNE 01, 2023 BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. BLOCK H11: BLOCK E1: INITIAL REPORTER FIRST NAME, HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON JULY 24, 2023.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS PLACED DURING A PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. POST-PROCEDURE, THE 7FR ADVANIX BILIARY STENT MIGRATED AND PERFORATED THROUGH THE PATIENT'S DUODENAL WALL. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS PLACED DURING A PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. POST-PROCEDURE, THE 7FR ADVANIX BILIARY STENT MIGRATED AND PERFORATED THROUGH THE PATIENT'S DUODENAL WALL. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233939 ADVANIX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention