BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR UROLOGICAL GUIDEWIRE

    MDR report key: 22105631 · Received May 29, 2025

    Report

    Report Number
    2124215-2025-34961
    Event Type
    Injury
    Date Received
    May 29, 2025
    Date of Event
    April 1, 2021
    Report Date
    May 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    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: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) UNIVERSITY. BLOCK G2: LITERATURE SOURCE: ZAGHLOUL, T., GAMEEL, T., MOUSA, A., TATAWY, H. EL, RAGAB, M., ABO-EL ENEIN, M., MAMDOH, H. (2024). COMPARISON OF LAPAROSCOPIC URETEROLITHOTOMY, RETROGRADE FLEXIBLE URETEROSCOPY, AND MINI-PERCUTANEOUS ANTEGRADE FLEXIBLE URETEROSCOPIC LITHOTRIPSY FOR TREATING LARGER THAN 15 MM IMPACTED PROXIMAL URETERIC STONES: A PROSPECTIVE RANDOMIZED TRIAL: UROLITHIASIS (2024) 52:10, HTTPS://DOI.ORG/10.1007/S00240-024-01602-2. BLOCK H6: IMDRF PATIENT CODE E2025 CAPTURES THE REPORTABLE EVENT OF UNSPECIFIED TISSUE INJURY. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E230101 CAPTURES THE REPORTABLE EVENT OF FEVER. IMDRF PATIENT CODE E2328 CAPTURES THE REPORTABLE EVENT OF OBSTRUCTION/OCCLUSION. IMDRF PATIENT CODE E1302 CAPTURES THE REPORTABLE EVENT OF HEMATURIA. IMDRF PATIENT CODE E0306CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT UNEXPECTED MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN UROLITHIASIS JOURNAL THAT A PROSPECTIVE RANDOMIZED STUDY WAS CONDUCTED TO COMPARE THE OUTCOMES OF TRANSPERITONEAL LAPAROSCOPIC URETEROLITHOTOMY (TPLU), RETROGRADE FLEXIBLE URETEROSCOPY (R-FURS) USING SENSOR WIRE, AND MINI-PERCUTANEOUS ANTEGRADE FLEXIBLE URETEROSCOPY (A-FURS) FOR TREATING LARGE URETERAL STONES. A TOTAL OF 105 PATIENTS PARTICIPATED AND WERE RANDOMIZED INTO 3 EQUAL GROUPS ACCORDING TO THE PROCEDURE PERFORMED (TPLU, R-FURS, A-FURS ). THE PATIENTS WERE ADMITTED TO THE HOSPITAL DURING THE PERIOD FROM APRIL 2021 TO APRIL 2023. AFTER THE PATIENTS UNDERWENT TO THE PROCEDURES, THERE WERE CERTAIN ADVERSE EVENTS EXPERIENCED BY THE PATIENTS, SUCH AS: MILD MUCOSAL INJURY, MINOR URETERAL PERFORATION, FAILED RETROGRADE ACCESS, AND FEVER; THE CASES WERE MANAGED BY ANTIPYRETICS AND ANTIBIOTICS. ANOTHER PERIOPERATIVE COMPLICATION FOUND ON PATIENTS WERE PARALYTIC ILEUS, HEMATURIA AND SEPSIS, WHICH WAS MANAGED WITH BROAD-SPECTRUM ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625587 SENSOR UROLOGICAL GUIDEWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O