BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIFLEX? RX DELIVERY SYSTEM

    MDR report key: 24436783 · Received February 24, 2026

    Report

    Report Number
    3005099803-2026-00720
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    December 1, 2025
    Report Date
    May 25, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729787105
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF CATHETER GUIDE BREAK. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF CATHETER GUIDE BREAK. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. BLOCK H11: INVESTIGATION RESULTS: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONFIRMED THE REPORTED EVENT OF CATHETER GUIDE BREAK. THE RETURNED NAVIFLEX DELIVERY SYSTEM WAS ANALYZED, AND THE INVESTIGATION REVEALED THAT THE GUIDE CATHETER HAD DETACHED FROM THE DELIVERY SYSTEM. UNDER MICROSCOPIC INSPECTION, RESIDUES WERE OBSERVED INSIDE THE CATHETER. SINCE THE DELIVERY SYSTEM WAS NOT RETURNED, IT WAS NOT POSSIBLE TO DETERMINE WHETHER A SPECIFIC CONDITION WITHIN THE DELIVERY SYSTEM CONTRIBUTED TO THE DETACHMENT OF THE GUIDE CATHETER. IN ADDITION, FOR THE EVENT OF "ADDITIONAL DEVICE REQUIRED," THIS OCCURRED DURING THE PROCEDURE. THE MOST PROBABLE CAUSE OF THIS REPORTED ISSUE COULD NOT BE ESTABLISHED DUE TO A LACK OF EVIDENCE. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE TECHNICAL ANALYSIS: THE NAVIFLEX DELIVERY SYSTEM WAS RETURNED AND ANALYZED. VISUAL INSPECTION REVEALED THAT ONLY THE GUIDE CATHETER WAS RETURNED, AND IT WAS DETACHED FROM THE DELIVERY SYSTEM. MICROSCOPIC INSPECTION IDENTIFIED RESIDUES INSIDE THE CATHETER. IN ADDITION, IT WAS NOT POSSIBLE TO OBTAIN AN INITIAL PHOTOGRAPH OF THE RETURNED DEVICE BECAUSE THE STENT, WHICH IS MOUNTED ON THE GUIDE CATHETER, IS IMPLANTABLE, AND PATIENT CONSENT WAS NOT RECEIVED. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. LABELING REVIEW: A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THERE IS NO INFORMATION THAT THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU)/ PRODUCT LABEL. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF CATHETER GUIDE BREAK AND ADDITIONAL DEVICE REQUIRED WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. PRODUCT RISK BENEFIT INCLUDES CONSIDERATION OF RISK SEVERITY AND RATE, AND THE OVERALL RESIDUAL RISK OF THE ADVANIX-NAVIFLEX DEVICE IS ACCEPTABLE. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED TO IMPLANT AN ADVANIX STENT IN THE COMMON BILE DUCT TO TREAT CHOLEDOCHOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER ADVANCING THE DELIVERY SYSTEM INTO THE BILE DUCT ACCORDING TO STANDARD PROTOCOL AND WITHDRAWING THE GUIDEWIRE, THE GUIDING CATHETER WAS LOCKED. AT THAT MOMENT, THE PLASTIC STENT AND GUIDE CATHETER UNEXPECTEDLY DETACHED FROM THE DELIVERY SYSTEM BEFORE REACHING ITS INTENDED POSITION, LEAVING A FRAGMENT OF APPROXIMATELY 30 CM INSIDE THE PATIENT. THE DEVICES WERE RETRIEVED, AND THE ADVANIX STENT WAS RE-MOUNTED ON A SECOND NAVIFLEX DELIVERY SYSTEM AND IMPLANTED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED TO IMPLANT AN ADVANIX STENT IN THE COMMON BILE DUCT TO TREAT CHOLEDOCHOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER ADVANCING THE DELIVERY SYSTEM INTO THE BILE DUCT ACCORDING TO STANDARD PROTOCOL AND WITHDRAWING THE GUIDEWIRE, THE GUIDING CATHETER WAS LOCKED. AT THAT MOMENT, THE PLASTIC STENT AND GUIDE CATHETER UNEXPECTEDLY DETACHED FROM THE DELIVERY SYSTEM BEFORE REACHING ITS INTENDED POSITION, LEAVING A FRAGMENT OF APPROXIMATELY 30 CM INSIDE THE PATIENT. THE DEVICES WERE RETRIEVED, AND THE ADVANIX STENT WAS RE-MOUNTED ON A SECOND NAVIFLEX DELIVERY SYSTEM AND IMPLANTED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46679 NAVIFLEX? RX DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00533580 0036756047 08714729787105

    Patients

    Seq Age Sex Outcome Treatment
    1