BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URINARY TRACT OCCLUSION BALLOON CATHETER

    MDR report key: 18728646 · Received February 18, 2024

    Report

    Report Number
    2124215-2024-09481
    Event Type
    Injury
    Date Received
    February 18, 2024
    Date of Event
    January 2, 2022
    Report Date
    February 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF JANUARY 2, 2022, WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE PROCEDURE WHICH HAPPENED SOMETIME IN 2022 AND THE ONSET OF EVENT AT ONE (1) DAY POST-PROCEDURE (POD01). BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF CANDIDA INFECTION. PATIENT CODE E1310 CAPTURES THE REPORTABLE EVENT OF UTI. IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITAL ADMISSION FOR TWO (2) DAYS. IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED FOR TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A URINARY TRACT OCCLUSION BALLOON CATHETER WAS USED DURING A LEFT PERCUTANEOUS NEPHROLITHOTOMY (L PCNL) PROCEDURE TO REMOVE A STONE PERFORMED SOMETIME IN 2022. ONLY ONE (1) OCCLUDER WAS USED AND NO OCCLUDER BALLOON WAS WASTED IN THE PROCEDURE. THERE WERE NO DEVICE MALFUNCTIONS NOR ANY INTRA-OPERATIVE COMPLICATIONS NOTED IN THE OPERATIVE NOTE AT THE CONCLUSION OF THE PROCEDURE. ONE (1) DAY POST-PROCEDURE (POD01), THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR FEVER AND URINARY TRACT INFECTION (UTI). THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TWO (2) DAYS. AN INTRA-OPERATIVE STONE CULTURE WAS POSITIVE FOR CANDIDA. THE PATIENT WAS TREATED WITH CEFEPIME AND FLUCONAZOLE. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS SERIOUS, WAS NOT RELATED TO THE DEVICE, AND CAUSALLY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541304 URINARY TRACT OCCLUSION BALLOON CATHETER CATHETER, UROLOGICAL KOD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other