BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX? BILIARY

    MDR report key: 22433133 · Received July 8, 2025

    Report

    Report Number
    3005099803-2025-03157
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 11, 2025
    Report Date
    July 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729787389
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: ADDITIONAL PREMARKET / 510(K) # K203162. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF PULL WIRE BREAK.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT A STONE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2025. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THEY CAREFULLY PUSHED THE STENT INTO THE BILE DUCT, AIMING TO RELEASE IT. AFTER REMOVING THE GUIDE WIRE, THEY NOTICED THE STEEL STYLET WAS SURPRISINGLY EASY TO PULL BACK. HOWEVER, THE BLACK CATHETER, WHICH HELD THE STENT, DID NOT RETRACT ALONG WITH IT, PREVENTING THE STENT FROM BEING RELEASED. IT APPEARED THAT THE STEEL STYLET HAD DISCONNECTED FROM THE BLACK CATHETER. ANOTHER ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965917 ADVANIX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00534290 0034951820 08714729787389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown