BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR UROLOGICAL GUIDEWIRE

    MDR report key: 22285296 · Received June 18, 2025

    Report

    Report Number
    2124215-2025-38165
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    January 1, 2013
    Report Date
    June 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT EVENT DATE IS UNKNOWN. THE PROVIDED EVENT DATE IS AN APPROXIMATE BASED ON THE RANGE THE PROCEDURES WERE PERFORMED. BLOCKS D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. 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 H6: PATIENT CODE E1302 CAPTURES THE REPORTABLE EVENT OF HEMATURIA. PATIENT CODE E1310 CAPTURES THE REPORTABLE EVENT OF URINARY TRACT INFECTION. PATIENT CODE E1020 CAPTURES THE REPORTABLE EVENT OF NAUSEA. PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. PATIENT CODE E1032 CAPTURES THE REPORTABLE EVENT OF VOMITING. PATIENT CODE E1309 CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION. IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE. LITERATURE SOURCE: PAULA GAYARRE ABRIL, BENJAMIN BLASCO BELTRAN, JORGE SUBIRA RIOS, DANIEL HIJAZO GASCON, VICTORIA CAPAPE POVES, CARLOS BLANCO CHAMORRO, MARIA RUT SIESO GRACIA, FRANCISCO XAVIER ELIZALDE BENITO, GONZALO ABRIL BAQUERO, PATRICIA CARRERA LASFUENTES, JORGE RIOJA ZUAZU. DOES TIME AND SIZE MATTER IN RETROGRADE INTRARENAL SURGERY? RESULTS ANALYSIS USING A LOW-PRESSURE TECHNIQUE. ARCH. ESP. UROL. 2023, 76(2): 107-113. HTTPS://DOI.ORG/10.56434/J.ARCH.ESP.UROL.20237602.11.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE ARCHIVOS ESPANOLES DE UROLOGIA THAT A STUDY WAS CONDUCTED THROUGH RETROGRADE INTRARENAL SURGERY AND PERCUTANEOUS NEPHROLITHOTOMY TREATMENTS AND THE ANALYSIS OF THE RESULTS FROM PATIENTS USING A LOW-PRESSURE TECHNIQUE. THIS RETROSPECTIVE STUDY ANALYZED 403 PATIENTS WHO UNDERWENT RETROGRADE INTRARENAL SURGERY (RIRS) FOR KIDNEY STONES BETWEEN 2013 AND 2019. THE AVERAGE SURGERY LASTED 111 MINUTES, AND THE AVERAGE STONE VOLUME WAS 3.5 ML. THE PROCEDURES WERE PERFORMED WITH THE PATIENT IN LITHOTOMY POSITION AND UNDER GENERAL ANESTHESIA. A SENSOR WIRE WAS INTRODUCED INTO THE RENAL CAVITIES UNDER FLUOROSCOPY. POSTOPERATIVE COMPLICATIONS INCLUDED: URINARY SYMPTOMS IN 2 PATIENTS, RENAL COLIC IN 5, PYELONEPHRITIS IN 7 CASES, 11 PATIENTS EXPERIENCED URINARY TRACT INFECTION, 1 DEVELOPED ACUTE URINARY RETENTION AND. 5 MORE PATIENTS ALSO REQUIRED INTENSIVE CARE. ADDITIONALLY, MINOR COMPLICATIONS WERE REPORTED, INCLUDING NAUSEA, VOMITING, OR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748283 SENSOR UROLOGICAL GUIDEWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC CORPORATION

    Patients

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