BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPHROMAX KIT

    MDR report key: 22893312 · Received August 26, 2025

    Report

    Report Number
    2124215-2025-59365
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    July 30, 2025
    Report Date
    August 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LJE
    UDI-DI
    08714729834526
    PMA / PMN Number
    K121614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF TIP BENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS BENT AND SQUASHED WHICH COULD CAUSE DAMAGE TO THE KIDNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711785 NEPHROMAX KIT CATHETER, NEPHROSTOMY LJE BOSTON SCIENTIFIC CORPORATION M0062101620 0034484879 08714729834526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown