BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPHROMAX

    MDR report key: 16335377 · Received February 9, 2023

    Report

    Report Number
    3005099803-2023-00497
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    October 1, 2017
    Report Date
    February 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LJE
    PMA / PMN Number
    K121614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: THE EXACT DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2017. THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE SUSPECTED UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. IMDRF PATIENT CODES E130501 AND E0506 CAPTURE THE REPORTABLE EVENT OF RENAL FAILURE AND HEMORRHAGE. IMDRF IMPACT CODES F23 CAPTURE THE REPORTABLE EVENT OF TRANSFUSION.

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT: THE EXACT DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2017. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE SUSPECTED DEVICE UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF PATIENT CODES E130501 AND E0506 CAPTURE THE REPORTABLE EVENT OF RENAL PROBLEM AND HEMORRHAGE. IMDRF IMPACT CODE F2302 CAPTURES THE REPORTABLE EVENT OF TRANSFUSION.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON, 8/10 DILATOR, PERCUTANEOUS ACCESS NEEDLE AND SHEATH IMAGER II SET WERE USED DURING A LEFT PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2017. DURING THE PROCEDURE, THE PATIENT EXPERIENCED HEMORRHAGE, ACUTE KIDNEY INJURY (AKI) AND REQUIRED TRANSFUSION.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON, 8/10 DILATOR SHEATH SET, PERCUTANEOUS ACCESS NEEDLE AND IMAGER II WERE USED DURING A LEFT PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2017. THE PATIENT EXPERIENCED HEMORRHAGE, ACUTE KIDNEY INJURY (AKI) AND REQUIRED TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358598 NEPHROMAX CATHETER, NEPHROSTOMY LJE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention