BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPHROMAX

    MDR report key: 16329618 · Received February 8, 2023

    Report

    Report Number
    3005099803-2023-00578
    Event Type
    Injury
    Date Received
    February 8, 2023
    Date of Event
    April 1, 2021
    Report Date
    April 20, 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

    BLOCK B3: DATE OF EVENT: THE EXACT DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN APRIL 2021. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE SUSPECTED UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H2: ADDITIONAL INFORMATION: BLOCK B5 (DESCRIBE EVENT OR PROBLEM). BLOCK H6: IMDRF PATIENT CODES E130501, E2328 AND E0742 CAPTURE THE REPORTABLE EVENT OF RENAL FAILURE, OBSTRUCTION, RESPIRATORY FAILURE. IMDRF IMPACT CODES F0801 AND F23 CAPTURE THE REPORTABLE EVENT OF INTENSIVE CARE AND UNEXPECTED MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: THE EXACT DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2021. 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, E2328 AND E0742 CAPTURE THE REPORTABLE EVENT OF RENAL FAILURE, OBSTRUCTION, RESPIRATORY FAILURE. IMDRF IMPACT CODES F0801 AND F23 CAPTURE THE REPORTABLE EVENT OF INTENSIVE CARE AND UNEXPECTED MEDICAL INTERVENTION.

    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) 2021. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE SUSPECTED UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF PATIENT CODES E130501, E2328 AND E0742 CAPTURE THE REPORTABLE EVENT OF RENAL FAILURE, COLONIC PSEUDO-OBSTRUCTION, RESPIRATORY FAILURE. IMDRF IMPACT CODES F0801, F23 AND F2303 CAPTURE THE REPORTABLE EVENT OF INTENSIVE CARE, UNEXPECTED MEDICAL INTERVENTION AND MEDICATION REQUIRED.

    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 AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2021. THE PATIENT EXPERIENCED ACUTE KIDNEY INJURY (AKI), OBSTRUCTION, AND RESPIRATORY FAILURE. THE PATIENT HAD UNDERGONE INTENSIVE CARE, A RAPID RESPONSE TEAM, AND BIPAP. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 5, 2023. THE PATIENT EXPERIENCED ACUTE KIDNEY INJURY (AKI), OBSTRUCTION, RESPIRATORY FAILURE AND COLONIC PSEUDO-OBSTRUCTION. THE PATIENT HAD UNDERGONE INTENSIVE CARE WITH OBSERVATION, A RAPID RESPONSE TEAM, AND BIPAP.

    Description of Event or Problem · 0

    THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2021. THE PATIENT EXPERIENCED ACUTE KIDNEY INJURY (AKI), OBSTRUCTION, AND RESPIRATORY FAILURE. THE PATIENT HAD UNDERGONE INTENSIVE CARE, A RAPID RESPONSE TEAM, AND BIPAP.

    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 AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2021. THE PATIENT EXPERIENCED ACUTE KIDNEY INJURY (AKI), OBSTRUCTION, AND RESPIRATORY FAILURE. THE PATIENT HAD UNDERGONE INTENSIVE CARE, A RAPID RESPONSE TEAM, AND BIPAP. ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 20, 2023: THE PATIENT EXPERIENCED ACUTE KIDNEY INJURY (AKI), COLONIC PSEUDO-OBSTRUCTION AND RESPIRATORY FAILURE. THE PATIENT HAD UNDERGONE INTENSIVE CARE AND WAS GIVEN INTRAVENOUS (IV) FLUIDS, A RAPID RESPONSE TEAM, AND BIPAP WITH OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280909 NEPHROMAX CATHETER, NEPHROSTOMY LJE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention| H