BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 22956244 · Received September 3, 2025

    Report

    Report Number
    2124215-2025-60002
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    May 29, 2021
    Report Date
    September 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS ARE KNOWN RISKS ASSOCIATED WITH THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. 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 UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE EVENT DATE WAS ASSIGNED ACCORDING TO THE ARTICLE PUBLISHED DATE. CITATION: MICHAEL, B., MARC F, BASTIEN G, BENJAMIN P., MICKAEL U. (2024). HEAD TO HEAD COMPARISON OF PROSTATIC URETHRAL LIFT AND WATER VAPOR THERMAL THERAPY FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA: A REAL LIFE STUDY. INTERNATIONAL UROLOGY AND NEPHROLOGY, 2021 (53), 1757- 1763.

    Additional Manufacturer Narrative · 0

    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 UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE EVENT DATE WAS ASSIGNED ACCORDING TO THE ARTICLE PUBLISHED DATE. CITATION: MICHAEL, B., MARC F, BASTIEN G, BENJAMIN P., MICKAEL U. (2024). HEAD-TO-HEAD COMPARISON OF PROSTATIC URETHRAL LIFT AND WATER VAPOR THERMAL THERAPY FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA: A REAL-LIFE STUDY. INTERNATIONAL UROLOGY AND NEPHROLOGY, 2021 (53), 1757- 1763.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE INTERNATIONAL UROLOGY AND NEPHROLOGY THAT A RETROSPECTIVE STUDY WAS TO PERFORM A HEAD-TO-HEAD COMPARISON BETWEEN WATER VAPOR THERMAL THERAPY USING THE REZUM SYSTEM AND PROSTATIC URETHRAL LIFT USING THE UROLIFT SYSTEM IN MEN WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA (BPH). A TOTAL OF 61 PATIENTS WHO UNDERWENT REZUM AND UROLIFT PROCEDURES IN TWO UROLOGY CENTERS HAVE BEEN RETROSPECTIVELY CONSIDERED, ONLY PATIENTS WITH A PROSTATE SIZE LESS THAN 80 ML WERE ENROLLED FROM DECEMBER 2017 TO NOVEMBER 2019. THE FOLLOWING BOSTON SCIENTIFIC PRODUCT WAS USED DURING THE PROCEDURES: REZUM DELIVERY DEVICE. REGARDING POSTOPERATIVE COMPLICATIONS, 3 PATIENTS DEVELOPED RETENTION, 2 PATIENTS EXPERIENCED GROSS HEMATURIA, AND 1 PATIENT HAD URINARY TRACT INFECTION. TWO PATIENTS REQUIRED A THIRTY-DAY READMISSION DUE TO THE HEMATURIA AND ACUTE URINARY RETENTION MENTIONED BEFORE. IT WAS ALSO REPORTED THAT ONE PATIENT REPORTED A DECREASE IN EJACULATORY VOLUME AND ANOTHER REPORTED ANEJACULATION. IT IS CONCLUDED THAT IN THIS SMALL RETROSPECTIVE STUDY, THE RESULTS INDICATE THAT BOTH REZUM AND UROLIFT PROVIDE A CLINICALLY SIGNIFICANT IMPROVEMENT IN SYMPTOMS AND QOL (QUALITY OF LIFE), ALTHOUGH SOME OF THESE IMPROVEMENTS WERE GREATER IN THE REZUM ARM. FUTURE STUDIES ARE NEEDED TO DEFINITIVELY ASSESS WHICH TREATMENT WOULD BE BEST SUITED FOR EACH PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE INTERNATIONAL UROLOGY AND NEPHROLOGY THAT A RETROSPECTIVE STUDY WAS TO PERFORM A HEAD-TO-HEAD COMPARISON BETWEEN WATER VAPOR THERMAL THERAPY USING THE REZUM SYSTEM AND PROSTATIC URETHRAL LIFT USING THE UROLIFT SYSTEM IN MEN WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA (BPH). A TOTAL OF 61 PATIENTS WHO UNDERWENT REZUM AND UROLIFT PROCEDURES IN TWO UROLOGY CENTERS HAVE BEEN RETROSPECTIVELY CONSIDERED, ONLY PATIENTS WITH A PROSTATE SIZE LESS THAN 80 ML WERE ENROLLED FROM (B)(6) 2017 TO (B)(6) 2019. THE FOLLOWING BOSTON SCIENTIFIC PRODUCT WAS USED DURING THE PROCEDURES: REZUM DELIVERY DEVICE. REGARDING POSTOPERATIVE COMPLICATIONS, 3 PATIENTS DEVELOPED RETENTION, 2 PATIENTS EXPERIENCED GROSS HEMATURIA, AND 1 PATIENT HAD URINARY TRACT INFECTION. TWO PATIENTS REQUIRED A THIRTY-DAY READMISSION DUE TO THE HEMATURIA AND ACUTE URINARY RETENTION MENTIONED BEFORE. IT WAS ALSO REPORTED THAT ONE PATIENT REPORTED A DECREASE IN EJACULATORY VOLUME AND ANOTHER REPORTED ANEJACULATION. IT IS CONCLUDED THAT IN THIS SMALL RETROSPECTIVE STUDY, THE RESULTS INDICATE THAT BOTH REZUM AND UROLIFT PROVIDE A CLINICALLY SIGNIFICANT IMPROVEMENT IN SYMPTOMS AND QOL (QUALITY OF LIFE), ALTHOUGH SOME OF THESE IMPROVEMENTS WERE GREATER IN THE REZUM ARM. FUTURE STUDIES ARE NEEDED TO DEFINITIVELY ASSESS WHICH TREATMENT WOULD BE BEST SUITED FOR EACH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234331 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H