BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 24948446 · Received April 21, 2026

    Report

    Report Number
    2124215-2026-21689
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    May 16, 2025
    Report Date
    May 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIU, B. W. H., LIU, A. Q., LEUNG, C. H., YUEN, S. K. K., LEUNG, D. K. W., WONG, C. H. M., KO, I. C. H., HO, J. M. H., YUEN, R. W. Y., MENG, H. Y. H., CHAN, Y. Y. Y., YEE, C. H., TEOH, J. Y. C., NG, C. F., CHIU, P. K. F., & LUN, L. K. (2026). TREATMENT CYCLES PER UNIT PROSTATE VOLUME (CPV) FOR TRANSURETHRAL WATER VAPOR THERAPY (REZUM) IN CATHETER-DEPENDENT PATIENTS. PROSTATE CANCER AND PROSTATIC DISEASES, 29(1), 132-137. HTTPS://DOI.ORG/10.1038/S41391-025-00979-4. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN PROSTATE CANCER AND PROSTATIC DISEASES THAT A PROSPECTIVE REGISTRY STUDY EVALUATED CATHETER-DEPENDENT PATIENTS UNDERGOING WATER VAPOR THERMAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA. PATIENTS INCLUDED IN THE STUDY UNDERWENT THE PROCEDURE USING THE REZUM SYSTEM BETWEEN FEBRUARY 2021 AND SEPTEMBER 2023. A TOTAL OF 168 PATIENTS WERE INCLUDED, WITH 144 PATIENTS ANALYZED AFTER PROPENSITY SCORE MATCHING. PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON TREATMENT INTENSITY DEFINED AS CYCLES PER UNIT PROSTATE VOLUME (CPV): A LOWER INTENSITY GROUP AND A HIGHER INTENSITY GROUP. THE MEDIAN AGE OF THE COHORT WAS APPROXIMATELY 72 YEARS. PREOPERATIVELY, ALL PATIENTS WERE CATHETER-DEPENDENT DUE TO REFRACTORY URINARY RETENTION ASSOCIATED WITH THE UNDERLYING DISEASE AND NOT ATTRIBUTED TO THE DEVICE. POSTOPERATIVELY, COMPLICATIONS WITHIN 30 DAYS INCLUDED READMISSIONS PRIMARILY DUE TO RECURRENT URINARY RETENTION, AS WELL AS URINARY TRACT INFECTIONS, HEMATURIA, FEVER, AND SEPSIS. URINARY TRACT INFECTION RATES WERE SIMILAR BETWEEN GROUPS, WHILE RECURRENT URINARY RETENTION WAS MORE FREQUENTLY OBSERVED IN THE LOWER CPV GROUP. NO SEVERE COMPLICATIONS (CLAVIEN-DINDO GRADE 3 OR HIGHER) WERE REPORTED. MEDIAN CATHETER REMOVAL TIME WAS APPROXIMATELY 14-15 DAYS. AT FOLLOW-UP, RECURRENT URINARY RETENTION PERSISTED IN BOTH GROUPS, WITH A HIGHER PROPORTION IN THE LOWER TREATMENT INTENSITY GROUP. SURGICAL RETREATMENT WAS RARE, WITH ONLY ONE CASE REPORTED. ADDITIONALLY, 15 PATIENTS UNDERWENT MEDICAL TREATMENT CONSISTING OF THE USE OF ALPHA BLOCKER AND/OR 5ARI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110911 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1