BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPHROSTOMY SHEATHS AND DILATORS

    MDR report key: 16712404 · Received April 11, 2023

    Report

    Report Number
    3005099803-2023-01916
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    May 1, 2016
    Report Date
    April 11, 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) 2016. THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE SUSPECTED UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. IMDRF PATIENT CODE E233605 CAPTURES THE REPORTABLE EVENT OF SEPTIC SHOCK. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE.

    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 (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED SEPTIC SHOCK AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BALLOON BUT WAS CAUSALLY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720099 NEPHROSTOMY SHEATHS AND DILATORS DILATOR, CATHETER EZN BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Required Intervention| H