BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIGATOR

    MDR report key: 25246680 · Received May 21, 2026

    Report

    Report Number
    2124215-2026-27514
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    February 27, 2026
    Report Date
    May 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT EVENT DATE IS UNKNOWN. THE EVENT DATE OF FEBRUARY 27, 2026, WAS CHOSEN BASED ON THE DATE THE ARTICLE WAS PUBLISHED. BLOCKS 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: DEPARTMENT OF UROLOGY, UNIVERSITY OF ALABAMA AT BIRMINGHAM BLOCK H6: PATIENT CODE E1310 CAPTURES THE REPORTABLE EVENT OF URINARY TRACT INFECTION. PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. PATIENT CODE E2015 CAPTURES THE REPORTABLE EVENT OF URETERAL INJURY. IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. BLOCK H11: INVESTIGATION RESULTS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THEREFORE, TECHNICAL ANALYSIS COULD NOT BE PERFORMED. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THERE WAS NO KNOWN DEVICE PROBLEM REPORTED AND THE PATIENT/IMPACT CODES REPORTED ARE CONDITIONS THAT COULD NOT BE TESTED, ANALYZED OR REPLICATED ON THE PRODUCT ANALYSIS LABORATORY. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF URINARY TRACT INFECTION, SEPSIS AND TISSUE DAMAGE WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. A LABELING REVIEW WAS PERFORMED AND THERE IS NO EVIDENCE THAT THE DEVICE WAS IMPROPERLY USED PER THE INSTRUCTIONS FOR USE (IFU). ADDITIONALLY, IT WAS CONFIRMED THAT THE REPORTED ADVERSE EVENTS OF URINARY TRACT INFECTION, SEPSIS AND TISSUE DAMAGE ARE ANTICIPATED PER IFU. THE INSTRUCTION FOR USE MENTIONS INFECTION, TISSUE DAMAGE, INFLAMMATION, AND EDEMA AS POTENTIAL COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE. BASED ON THE INFORMATION AVAILABLE AND INVESTIGATION RESULTS, AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. LITERATURE SOURCE: WEI-JEN CHEN, FERES CAMARGO MALUF, HANNAH JARVIS, ZACHARY BURNS, VICENTE ELORRIETA, JOSEPH CRIVELLI, THOMAS CHI, DEAN G. ASSIMOS, KYLE D. WOOD: IS 3 CM THE UPPER LIMIT OF STONE SIZE FOR EFFECTIVE STEERABLE URETEROSCOPIC RENAL STONE EVACUATION, WORLD JOURNAL OF UROLOGY (2026) 44:208, HTTPS://DOI.ORG/10.1007/S00345-026-06310-7.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN WORLD JOURNAL OF UROLOGY ON THE STUDY TO DETERMINE THE IDEAL SIZE AND VOLUME THRESHOLDS USING CONTROLLED VACUUM ASSISTED CLEARANCE SYSTEM (CVAC) FOR STEERABLE URETEROSCOPIC RENAL EVACUATION. A RETROSPECTIVE STUDY EVALUATES THE SAFETY AND EFFICACY OF THE STEERABLE URETEROSCOPIC RENAL EVACUATION (SURE) PROCEDURE FOR THE TREATMENT OF RENAL STONES, CONDUCTED BETWEEN AUGUST 2023 AND APRIL 2025. THE RESEARCH AIMED TO DEFINE THE IDEAL STONE SIZE AND VOLUME THRESHOLDS FOR SUCCESSFUL EVACUATION USING VACUUM ASSISTED TECHNOLOGY. THE STUDY COHORT WAS HIGH-RISK, CONSISTING OF 50 PATIENTS TO ANALYZE 55 KIDNEYS WHERE 82 PERCENT WERE CLASSIFIED AS AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) CLASS 3 OR 4, INDICATING THEY SUFFERED FROM SEVERE SYSTEMIC DISEASES. USING PREOPERATIVE COMPUTED TOMOGRAPHY (CT) SCANS TO QUANTIFY STONE BURDEN, THE STUDY CONFIRMED THAT THE STEERABLE URETEROSCOPIC RENAL EVACUATION (SURE) PROCEDURE IS A HIGHLY VIABLE OPTION FOR COMPLEX PATIENTS. THE INTEGRATION OF NEWER ASPIRATION TECHNOLOGY ALLOWED FOR EFFECTIVE STONE CLEARANCE WHILE MAINTAINING A MINIMALLY INVASIVE APPROACH. THE PROCEDURE DEMONSTRATED A STRONG SAFETY PROFILE WITH AN OVERALL COMPLICATION RATE OF 12 PERCENT. SIGNIFICANTLY, THERE WERE NO HIGH-GRADE COMPLICATIONS, ONLY MINOR ISSUES OF PERIRENAL FLUID COLLECTION AND STANDARD URINARY TRACT INFECTIONS (UTIS). ONE GRADE 2 INJURY OCCURRED DURING URETERAL ACCESS SHEATH (UAS) INSERTION, AND IT WAS SUCCESSFULLY RESOLVED WITH A 6-WEEK INDWELLING STENT, WITH FOLLOW-UP SCANS SHOWING NORMAL KIDNEY FUNCTION. WHILE 4 PERCENT OF PATIENTS DEVELOPED SEPSIS, THESE CASES WERE ASSOCIATED WITH HIGH-RISK FACTORS AND RESULTED IN UNEVENTFUL RECOVERIES FOLLOWING MEDICAL MANAGEMENT. THE RESEARCHERS CONCLUDED THAT THE STEERABLE URETEROSCOPIC RENAL EVACUATION (SURE) PROCEDURE WITH CONTROLLED VACUUM ASSISTED CLEARANCE SYSTEM (CVAC) TECHNOLOGY IS A SAFE AND EFFECTIVE TREATMENT FOR RENAL STONES, EVEN IN MEDICALLY FRAGILE PATIENTS. WHILE THESE INITIAL RESULTS ARE PROMISING FOR ESTABLISHING SIZE AND VOLUME THRESHOLDS, THE STUDY RECOMMENDS LARGER RANDOMIZED TRIALS TO STANDARDIZE THE PROCEDURE FOR BROADER CLINICAL APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559323 NAVIGATOR ENDOSCOPE AND/OR ACCESSORIES KOD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other