BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UROMAX ULTRA

    MDR report key: 21445097 · Received February 24, 2025

    Report

    Report Number
    2124215-2025-10579
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    April 1, 2016
    Report Date
    February 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE OF EVENT IS UNKNOWN; THEREFORE, FIRST DAY OF TREATMENT MONTH/YEAR HAS BEEN SELECTED. BLOCK 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 E230101 CAPTURES THE REPORTABLE EVENT FEVER. PATIENT CODE E1302 CAPTURES THE REPORTABLE EVENT OF HEMATURIA. PATIENT CODE E2015 CAPTURES THE REPORTABLE EVENT OF TISSUE DAMAGE. IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. LITERATURE SOURCE: MOHAMED OMAR, MOHAMMED DORRAH, AHMED KHALIFA, EID EL SHERIF, KHALID SAYEDAHMED, YAHYA GHAZWANI, YASSER A. NOURELDIN. RANDOMIZED COMPARISON OF 4.5/6 FR VERSUS 6/7.5 FR URETEROSCOPES FOR LASER LITHOTRIPSY OF LOWER/MIDDLE URETERAL CALCULI: TOWARDS OPTIMIZATION OF EFFICACY AND SAFETY OF SEMIRIGID URETEROSCOPY. WORLD JOURNAL OF UROLOGY (2022) 40:3075-3081, HTTPS://DOI.ORG/10.1007/S00345-022-04173-2.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN WORLD JOURNAL OF UROLOGY THAT A STUDY WAS CONDUCTED TO COMPARE 4.5/6 FR VERSUS 6/7.5 FR SEMIRIGID URETEROSCOPES IN TERMS OF SAFETY AND EFFICACY IN ADULT NON-OBESE PATIENTS WITH MIDDLE OR LOWER URETERIC STONES. A TOTAL OF 198 PATIENTS WITH MIDDLE/LOWER URETERIC STONE WERE RECRUITED, WITH THE PROCEDURES BEING PERFORMED BETWEEN APRIL 2016 AND MAY 2019. ALL PROCEDURES WERE PERFORMED UNDER SPINAL ANESTHESIA WITH THE PATIENTS PLACED IN THE LITHOTOMY POSITION; AND DURING THE SURGERIES, ZERO TIP BASKETS, SENSOR WIRES AND UROMAX BALLOON WERE USED. WITHIN THE REPORTED COMPLICATIONS IT WAS MENTIONED THAT 19 PATIENTS EXPERIENCED URETERAL INJURY, 9 PATIENTS EXPERIENCED HEMATURIA, 19 PATIENTS EXPERIENCED FEVER AND IN 76 CASES PROLONGED HOSPITALIZATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408690 UROMAX ULTRA DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R