BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX BILIARY

    MDR report key: 18679232 · Received February 9, 2024

    Report

    Report Number
    3005099803-2024-00363
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    December 5, 2023
    Report Date
    February 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729787440
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A040611 CAPTURES THE REPORTABLE INVESTIGATION FINDING OF GUIDE CATHETER DETACHED/SEPARATED. BLOCK H10: AN ADVANIX NAVIFLEX BILIARY WAS RECEIVED FOR ANALYSIS. VISUAL INSPECTION REVEALED THAT THE GUIDE CATHETER WAS DETACHED FROM THE DELIVERY SYSTEM, WHILE NO DAMAGES WERE NOTED ON THE DELIVERY SYSTEM. MICROSCOPIC INSPECTION FOUND THAT THE SUTURE HOLE WAS TORN. NO OTHER PROBLEMS WERE NOTED WITH THE STENT OR DELIVERY SYSTEM. BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT OF GUIDE CATHETER STRETCHED CANNOT BE CONFIRMED. ADDITIONALLY, DETACHED GUIDE CATHETER AND SUTURE HOLE TORN WERE MOST LIKELY DUE TO PROCEDURAL FACTORS AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED), COULD HAVE RESULTED IN THE DAMAGES ENCOUNTERED IN THE DEVICE, THESE DAMAGES COULD HAVE BEEN PERCEIVED AS STRETCHED IN THE GUIDE CATHETER DURING THE PROCEDURE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    PROCEDURE SUMMARY: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY WAS TO BE IMPLANTED TO TREAT STRICTURES IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. EVENT SUMMARY: DURING PREPARATION, THE BLACK GUIDE CATHETER WAS STRETCHED. ANOTHER ADVANIX NAVIFLEX STENT WAS USED TO COMPLETE THE PROCEDURE. PATIENT STATUS: THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER DETACHED/SEPARATED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51244 ADVANIX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00534350 0032625120 08714729787440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown