BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX BILIARY

    MDR report key: 21102215 · Received January 8, 2025

    Report

    Report Number
    3005099803-2024-06806
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 1, 2024
    Report Date
    January 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729787181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: PREMARKET/510(K): K101314, K203162; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED. BLOCK H6: IMDRF DEVICE CODE A020503 CAPTURES THE REPORTABLE EVENT OF PACKAGING NO SEAL. IMDRF DEVICE CODE A1801 CAPTURES THE REPORTABLE EVENT OF DEVICE NOT STERILE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORTATION THAT AN ADVANIX RX BILIARY PRELOADED STENT WAS TO BE USED IN A PROCEDURE. DURING PREPARATION, IT WAS OBSERVED THAT THE PRIMARY PACKAGING WAS UNSEALED, WITH NO EVIDENCE OF HEAT SEALING ON THE LOWER PORTION OF THE PACKAGING. AS A RESULT, THE PRODUCT WAS DEEMED NON-STERILE AND UNSUITABLE FOR USE. NO PATIENT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348765 ADVANIX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00534630 0034897781 08714729787181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown