BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPHROSTOMY SHEATHS AND DILATORS

    MDR report key: 16338008 · Received February 9, 2023

    Report

    Report Number
    3005099803-2023-00609
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    February 1, 2021
    Report Date
    February 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZN
    PMA / PMN Number
    K851144
    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) 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 E233605 AND E0743 CAPTURE THE REPORTABLE EVENT OF SEPTIC SHOCK AND RESPIRATORY INSUFFICIENCY. IMDRF IMPACT CODES F0801 AND F23 CAPTURE THE REPORTABLE EVENT OF INTENSIVE CARE AND UNEXPECTED MEDICAL INTERVENTION.

    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 LEFT PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2021. THE PATIENT EXPERIENCED SEPTIC SHOCK AND RESPIRATORY DECOMPENSATION. IT WAS REPORTED THAT THE PATIENT WAS INTUBATED AND WAS SENT TO THE INTENSIVE CARE UNIT (ICU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358776 NEPHROSTOMY SHEATHS AND DILATORS DILATOR, CATHETER EZN BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention| H