BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZ SUPER STIFF

    MDR report key: 17292117 · Received July 10, 2023

    Report

    Report Number
    3005099803-2023-03614
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    June 15, 2023
    Report Date
    November 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    UDI-DI
    08714729191186
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: THE EXACT AGE OF THE PATIENT IS UNKNOWN. HOWEVER, IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS OLD. BLOCK H6 (IMPACT CODE): IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. BLOCK H6 (DEVICE CODE): IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF CORE WIRE BROKEN. BLOCK H10: THE RETURNED AMPLATZ SUPER STIFF WAS ANALYZED, A VISUAL AND MICROSCOPIC EVALUATION NOTED THAT THE COIL WIRE UNRAVELED DUE TO THE CORE WIRE FOUND DETACHED APPROXIMATELY 2.6 CM FROM DISTAL TIP TO THE TRANSITION POINT. ADDITIONALLY, THE CORE WIRE WAS KINKED IN THE DISTAL SECTION. MEDIA INSPECTION SHOWS THAT THE CORE WIRE WAS DETACHED AND SEPARATED AT THE TRANSITION POINT. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT OF CORE WIRE BREAK AND DEVICE UNRAVELED MATERIAL WAS CONFIRMED. BASED ON THE CONDITION OF THE RETURNED DEVICE, IT IS PROBABLE THAT THE FUNCTIONALITY OF THE DEVICE COULD BE AFFECTED BY AN EXCESS OF FORCE, MANIPULATION, AND THE TECHNIQUE USED COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THEREFORE, THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS MANUFACTURING DEFICIENCY.

    Additional Manufacturer Narrative · 0

    BLOCK A2: THE EXACT AGE OF THE PATIENT IS UNKNOWN. HOWEVER, IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS OLD. BLOCK H6 (IMPACT CODE): IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. BLOCK H6 (DEVICE CODE): IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF CORE WIRE BROKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE ON JUNE 15, 2023. DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS PLACED INSIDE THE PATIENT, IT UNRAVELED, AND THE CORE WIRE BROKE. REPORTEDLY, THE BROKEN TIP WAS RETRIEVED. THE PHYSICIAN USED A SECOND AMPLATZ GUIDEWIRE, AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS PLACED INSIDE THE PATIENT, IT UNRAVELED, AND THE CORE WIRE BROKE. REPORTEDLY, THE BROKEN TIP WAS RETRIEVED. THE PHYSICIAN USED A SECOND AMPLATZ GUIDEWIRE, AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND 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
    181189 AMPLATZ SUPER STIFF STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC CORPORATION M0066401081 0027969872 08714729191186

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other