BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX BILIARY

    MDR report key: 20853362 · Received December 5, 2024

    Report

    Report Number
    3005099803-2024-06217
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    October 30, 2024
    Report Date
    December 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729787297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK G4: PREMARKET/510(K): K101314, K203162; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABORTED/CANCELLED PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE USED IN THE COMMON BILE DUCT FOR DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS NOT COMPLETED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049929 ADVANIX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00534200 0034226134 08714729787297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown