BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX BILIARY

    MDR report key: 21201945 · Received January 21, 2025

    Report

    Report Number
    3005099803-2025-00134
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    November 8, 2024
    Report Date
    January 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729787204
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. K101314, K203162 - REPORTED HERE AS IT EXCEEDED THE MAXIMUM CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE G0401 CAPTURES THE REPORTABLE EVENT OF CATHETER GUIDE BREAK. AN ADVANIX-NAVIFLEX STENT WAS RECEIVED FOR ANALYSIS; THE DEVICE WAS RETURNED. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE PULL WIRE KINKED AND THE GUIDE CATHETER DETACHED AND KINKED. AFTER THE DESTRUCTIVE TEST, IT WAS SEEN THAT THE PULL WIRE WAS BROKEN, AND WHICH CAUSED THE GUIDE CATHETER DETACHMENT. NO OTHER PROBLEMS WERE NOTED WITH THE DELIVERY SYSTEM. PRODUCT ANALYSIS CONFIRMED THE REPORTED EVENTS OF "STENT FAILURE TO DEPLOY", "CATHETER - GUIDE DETACHED/SEPARATED", "CATHETER - GUIDE BENT/KINKED", "WIRE PULL BENT/KINKED" AND "WIRE PULL DETACHED/SEPARATED". THE INVESTIGATION CONCLUDED THAT THE ADVERSE EVENT WAS RELATED TO THE PROCEDURE. IT WAS REPORTED THAT THE GUIDE WIRE COULD NOT BE RELEASED DURING THE STENT DEPLOYMENT, LEADING THE PHYSICIAN TO FORCIBLY REMOVE THE INNER SHEATH, WHICH DAMAGED THE DELIVERY SYSTEM. THE RETURNED DEVICE SHOWED A KINKED PULL WIRE AND A DETACHED, KINKED GUIDE CATHETER. DESTRUCTIVE TESTING REVEALED A BROKEN PULL WIRE, WHICH CAUSED THE GUIDE CATHETER DETACHMENT. THE LIKELY CAUSE WAS THE TORTUOSITY OF THE PROCEDURE OR THE PHYSICIAN'S TECHNIQUE, WHICH REQUIRED EXCESSIVE FORCE TO DEPLOY THE STENT, RESULTING IN THE PULL WIRE DETACHMENT AND GUIDE CATHETER BREAKAGE. ALTERNATIVELY, THE GUIDE CATHETER MAY HAVE ALREADY BEEN KINKED BEFORE THE DEPLOYMENT ATTEMPT DUE TO THE TECHNIQUE USED. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE OVERALL ROOT 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 NAVIFLEX STENT WAS USED FOR DRAINAGE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE PHYSICIAN REMOVED THE GUIDEWIRE IN PREPARATION FOR RELEASING THE STENT, HE NOTICED THAT THE STENT COULD NOT BE RELEASED. THE INNER SHEATH WAS FORCIBLY PULLED OUT THAT CAUSED THE DELIVERY SYSTEM DAMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO KNOWN PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722585 ADVANIX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00534650 0033741467 08714729787204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown