BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX BILIARY

    MDR report key: 21307170 · Received February 4, 2025

    Report

    Report Number
    3005099803-2025-00270
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    November 8, 2024
    Report Date
    February 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729787143
    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

    BLOCK G4: PREMARKET 510(K): K101314, K203162 - REPORTED HERE AS IT EXCEEDED THE MAXIMUM CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0401 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF STENT BREAK. BLOCK H11: AN ADVANIX RX BILIARY PRELOADED STENT WAS RECEIVED FOR ANALYSIS. DURING THE DEVICE ANALYSIS, THE DEVICE WAS RETURNED WITH THE GUIDE CATHETER DETACHED, KINKED, AND STRETCHED. THE PULL WIRE WAS DISLODGED FROM THE PUSH CATHETER. ADDITIONALLY, DURING THE DESTRUCTIVE TEST, IT WAS OBSERVED THAT THE PULL WIRE WAS KINKED NEAR THE HYPO TUBE. FURTHERMORE, A PHOTO OF THE DEVICE WAS PROVIDED. NO OTHER ISSUES WERE NOTED WITH THE DELIVERY SYSTEM. PRODUCT ANALYSIS CONFIRMED THE EVENTS OF STENT FAILURE TO DEPLOY AND PULL WIRE KINKED. ANALYSIS ALSO FOUND THAT THE PULL WIRE WAS DISLODGED OUT OF THE PUSH CATHETER AND WAS KINKED NEAR THE HYPOTUBE. THE INVESTIGATION FOUND IT LIKELY THAT WHEN THEY TRIED TO DEPLOY THE STENT, THE TORTUOSITY OF THE PROCEDURE OR THE PHYSICIAN TECHNIQUE MADE THE DEVICE NOT ABLE TO DEPLOY THE STENT, WHICH MADE THE PHYSICIAN USE MORE FORCE TO DEPLOY THE STENT AND BY THIS MANIPULATION, THE GUIDE CATHETER ENDED UP GETTING KINKED, STRETCHED AND LATER THE GUIDE CATHETER WOULDN'T HOLD THIS PRESSURE GETTING DETACHED. THE FORCE APPLIED TO DEPLOY THE STENT COMBINED WITH THE CONDITIONS SEEN ON THE DEVICE PROBABLY MADE THE PULL WIRE GET DISLODGED OUT OF THE PUSH CATHETER AND BECOME KINKED BY THE PRESSURE THAT IT WAS USED DURING DEPLOYMENT. THEREFORE, A REVIEW AND ANALYSIS OF ALL COMPILED INFORMATION FROM THIS INVESTIGATION DETERMINE THAT THE MOST PROBABLE CAUSE IS "ADVERSE EVENT RELATED TO PROCEDURE."

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE PHYSICIAN REMOVED THE GUIDE WIRE IN PREPARATION FOR RELEASING THE STENT, IT WAS FOUND THAT IT COULD NOT BE RELEASED. THE INNER SHEATH WAS THEN FORCIBLY PULLED OUT, CAUSING DAMAGE TO THE DELIVERY SYSTEM. ADDITIONAL INFORMATION STATED THAT THE PUSHER WIRE HAD BEEN DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246084 ADVANIX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00534590 0034281649 08714729787143

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown