BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIFLEX RX DELIVERY SYSTEM

    MDR report key: 18616830 · Received January 31, 2024

    Report

    Report Number
    3005099803-2024-00182
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    January 5, 2024
    Report Date
    March 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729787082
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF CATHETER-GUIDE BREAK. IMDRF DEVICE CODE F2301 CAPTURES THE FORCEPS USED TO RETRIEVE THE DETACHED CATHETER-GUIDE.

    Additional Manufacturer Narrative · 0

    BLOCKS D4 (LOT NUMBER, EXPIRATION DATE) AND H4 HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 08, 2024. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF CATHETER-GUIDE BREAK. IMDRF DEVICE CODE F2301 CAPTURES THE FORCEPS USED TO RETRIEVE THE DETACHED CATHETER-GUIDE. BLOCK H10: A NAVIFLEX RX DELIVERY SYSTEM WAS RECEIVED FOR ANALYSIS. THE DELIVERY SYSTEM WAS RECEIVED WITH THE GUIDEWIRE BEING STUCK. VISUAL INSPECTION FOUND THE GUIDE CATHETER DETACHED FROM THE DELIVERY SYSTEM. NO OTHER PROBLEMS WERE NOTED WITH THE DELIVERY SYSTEM. PRODUCT ANALYSIS CONFIRMED THE REPORTED EVENT OF CATHETER-GUIDE BREAK. HOWEVER, THE REPORTED EVENTS OF PULL WIRE RETRACTION PROBLEM AND PUSH CATHETER BREAK WERE NOT CONFIRMED BECAUSE THE PUSH CATHETER WAS FOUND IN GOOD CONDITION AND THE PULL WIRE WAS COMPLETELY USED. IT IS MOST LIKELY THAT PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, AND THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED) RESULTED IN THE CATHETER-GUIDE BEING DETACHED FROM THE DELIVERY SYSTEM AND THE GUIDEWIRE BEING STUCK IN THE DELIVERY SYSTEM. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED TO TREAT CHOLEDOCHOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE INTRODUCER WAS PULLED BACK TO RELEASE THE STENT; HOWEVER, IT BECAME STUCK AND WAS TORE OFF. CONSEQUENTLY, BOTH THE GUIDE CATHETER AND THE PUSH CATHETER WERE BROKEN. THE GUIDE CATHETER WAS REMOVED USING FORCEPS AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS 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 TREAT CHOLEDOCHOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE INTRODUCER WAS PULLED BACK TO RELEASE THE STENT; HOWEVER, IT BECAME STUCK AND WAS TORE OFF. CONSEQUENTLY, BOTH THE GUIDE CATHETER AND THE PUSH CATHETER WERE BROKEN. THE GUIDE CATHETER WAS REMOVED USING FORCEPS AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109307 NAVIFLEX RX DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00533560 0031244943 08714729787082

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention