BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX? BILIARY

    MDR report key: 23429983 · Received October 30, 2025

    Report

    Report Number
    3005099803-2025-05698
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    August 18, 2025
    Report Date
    October 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729787396
    PMA / PMN Number
    K203162
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE INVESTIGATION FINDING OF GUIDE CATHETER BREAK. BLOCK G4: K101314 PRO CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H11: AN ADVANIX BILIARY STENT WAS RECEIVED FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND NO DAMAGES. HOWEVER, DESTRUCTIVE TEST WAS PERFORMED, AND IT WAS OBSERVED THAT THE GUIDE CATHETER WAS SMASHED UNDER MICROSCOPE INSPECTION. FUNCTIONAL INSPECTION WAS PERFORMED, AND IT WAS OBSERVED THAT THE GUIDE CATHETER WAS DIFFICULT TO ADVANCE AND PULL AND IT WAS DIFFICULT TO ADVANCE/LOAD THE GUIDEWIRE INTO THE DEVICE. NO OTHER PROBLEMS WERE NOTED WITH THE STENT AND DELIVERY SYSTEM. PRODUCT ANALYSIS CONFIRMED THE REPORTED EVENT OF DEVICE DIFFICULT TO ADVANCE GUIDEWIRE AS THE GUIDE CATHETER WAS DIFFICULT TO ADVANCE AND PULL AND IT WAS DIFFICULT TO ADVANCE/LOAD THE GUIDEWIRE INTO THE DEVICE DURING FUNCTIONAL ANALYSIS. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE INVESTIGATION CONCLUDED THAT THE REPORTED AND OBSERVED EVENTS WERE LIKELY DUE TO PROCEDURAL FACTORS, SUCH AS IMPROPER HANDLING OR EXCESSIVE MANIPULATION DURING GUIDEWIRE INSERTION, WHICH MAY HAVE CAUSED THE DAMAGE TO THE GUIDE CATHETER. THEREFORE, THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS ADVERSE EVENT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDEWIRE WAS UNABLE TO EXIT THE RX PORT DESPITE MULTIPLE ATTEMPTS. THE DEVICE WAS REMOVED, AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE GUIDE CATHETER WAS SMASHED. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297477 ADVANIX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00534300 0036742088 08714729787396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown