BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPHROSTOMY CATHETER SETS

    MDR report key: 21343140 · Received February 10, 2025

    Report

    Report Number
    2124215-2025-03635
    Event Type
    Injury
    Date Received
    February 10, 2025
    Date of Event
    December 19, 2024
    Report Date
    February 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GBO
    UDI-DI
    08714729009733
    PMA / PMN Number
    K820867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: THE PATIENT WAS REPORTED TO BE BETWEEN 71-80 YEARS OLD. BLOCK B3: THE EVENT DATE WAS APPROXIMATED BASED ON THE PROCEDURE DATE. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF "BLEEDING REQUIRING INTERVENTION." IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF "ANGIOEMBOLIZATION WAS PERFORMED FOR RENAL BLEEDING AND OTHER ADDITIONAL INTERVENTION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEPHROSTOMY CATHETER SET WAS USED TO ESTABLISH PERCUTANEOUS NEPHROSTOMY ACCESS AND URINE DRAINAGE DURING A PERCUTANEOUS NEPHROSTOMY WITH PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2024. FOLLOWING HOSPITAL DISCHARGE, THE PATIENT EXPERIENCED BLEEDING DURING THE CATHETER INDWELLING PERIOD, REQUIRING INTERVENTION. ANGIOEMBOLIZATION WAS PERFORMED FOR RENAL BLEEDING, THOUGH DETAILS OF ANY ADDITIONAL INTERVENTION WERE NOT REPORTED. THE CATHETER WAS REMOVED ON (B)(6) 2024, WITH NO SERIOUS ADVERSE EVENTS REPORTED IN CONNECTION TO THIS INCIDENT. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957676 NEPHROSTOMY CATHETER SETS CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO BOSTON SCIENTIFIC CORPORATION M0064201110 08714729009733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R