BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPHROSTOMY CATHETER SETS

    MDR report key: 21260279 · Received January 28, 2025

    Report

    Report Number
    2124215-2025-03682
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    December 2, 2024
    Report Date
    January 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GBO
    UDI-DI
    08714729009733
    PMA / PMN Number
    K820867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: THE PATIENT WAS REPORTED TO BE BETWEEN 61-70 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 DEVICE CODE A051201 CAPTURES THE REPORTABLE EVENT OF CATHETER DISLODGEMENT.

    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 PROCEDURE PERFORMED ON (B)(6) 2024. FOLLOWING THE PROCEDURE, THE PATIENT PULLED ON TUBE POST PROCEDURE AND DISLODGED IT FROM COLLECTING SYSTEM. THE CATHETER WAS REMOVED ON (B)(6) 2024. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2376304 NEPHROSTOMY CATHETER SETS CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO BOSTON SCIENTIFIC CORPORATION M0064201110 08714729009733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male