BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR UROLOGICAL GUIDEWIRE

    MDR report key: 22285294 · Received June 18, 2025

    Report

    Report Number
    2124215-2025-38693
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    June 1, 2021
    Report Date
    June 18, 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 G2: LITERATURE SOURCE: ALI, A. I., ABDELFADEL, A., ROHIEM, M., HASSAN, A. SEMIRIGID URETEROSCOPY AND TAMSULOSIN THERAPY AS DILATATION METHODS BEFORE FLEXIBLE URETEROSCOPY: EVALUATION AND BENEFITS. WORLD JOURNAL OF UROLOGY (2024) 42:75, HTTPS://DOI.ORG/10.1007/S00345-023-04696-2. BLOCK H6: IMDRF PATIENT CODE E2009 CAPTURES THE REPORTABLE EVENT OF HEMATURIA. IMDRF PATIENT CODE E230101 CAPTURES THE REPORTABLE EVENT OF FEVER. IMDRF PATIENT CODE E2009 CAPTURES THE REPORTABLE EVENT OF LACERATION IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN WORLD JOURNAL OF UROLOGY THAT A PROSPECTIVE RANDOMIZED STUDY WAS CONDUCTED TO EVALUATE THE EFFECT OF SEMIRIGID URETEROSCOPY AND TAMSULOSIN THERAPY AS DILATATION METHODS BEFORE FLEXIBLE URETEROSCOPY ADVANCEMENT TO THE RENAL COLLECTING SYSTEM. THE PROSPECTIVE STUDY INCLUDED 170 PATIENTS WHO PRESENTED WITH RENAL STONES SUITABLE FOR TREATMENT WITH FURS FROM JUNE 2021 TO SEPTEMBER 2022. THE PATIENTS WERE PLACED IN THE LITHOTOMY POSITION, AND DIAGNOSTIC CYSTOSCOPY WAS PERFORMED. MOREOVER, A SENSOR WIRE WAS INTRODUCED INTO THE KIDNEY UNDER FLUOROSCOPIC GUIDANCE. AFTER THE PROCEDURE, THE PATIENTS DEVELOPED FEVER, REQUIRED ANALGESICS AND SHOWED GROSS HEMATURIA. FURTHERMORE, THE PATIENTS EXHIBITED SYMPTOMS RELATED TO THE LOWER URINARY TRACT, WHICH INCLUDED INJURIES TO THE URETERS. ALL URETERAL INJURIES WERE EFFECTIVELY ADDRESSED THROUGH THE INSERTION OF JJ STENTS, RESULTING IN SYMPTOM RELIEF. AS A RESULT, THE ADVERSE EVENT OF HEMATURIA AMONG PATIENTS WHO UNDERWENT URETEROSCOPY AND LASER LITHOTRIPSY WAS DECREASED WITH THE ADMINISTRATION OF TAMSULOSIN, WHILE THE FREQUENCY OF POSTOPERATIVE FEVER ALSO LESSENED, AND THE USE OF TAMSULOSIN CONTRIBUTED TO A DECLINE IN THE OCCURRENCE OF HEMATURIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748281 SENSOR UROLOGICAL GUIDEWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R