BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 15143459 · Received August 2, 2022

    Report

    Report Number
    2124215-2022-28142
    Event Type
    Injury
    Date Received
    August 2, 2022
    Date of Event
    January 1, 2022
    Report Date
    September 30, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MICHAEL TZENG, SPYRIDON P. BASOURAKOS, PATRICK J. LEWICKI, JIM C. HU, AND RICHARD K. LEE. "NEW ENDOSCOPIC IN-OFFICE SURGICAL THERAPIES FOR BENIGN PROSTATIC HYPERPLAISA: A SYSTEMATIC REVIEW." EUROPEAN UROLOGY FOCUS 8 (2022) 522-531. HTTPS://DOI.ORG/10.1016/J.EUF.2021.02.013.

    Additional Manufacturer Narrative · 0

    MICHAEL TZENG, SPYRIDON P. BASOURAKOS, PATRICK J. LEWICKI, JIM C. HU, AND RICHARD K. LEE. "NEW ENDOSCOPIC IN-OFFICE SURGICAL THERAPIES FOR BENIGN PROSTATIC HYPERPLAISA: A SYSTEMATIC REVIEW." EUROPEAN UROLOGY FOCUS 8 (2022) 522-531. HTTPS://DOI.ORG/10.1016/J.EUF.2021.02.013 THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS AND THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION DURING TREATMENT. THE REPORTED PATIENT SYMPTOMS ARE KNOWN RISKS ASSOCIATED WITH PROCEDURES USING THESE DEVICE AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN EUROPEAN UROLOGY FOCUS THAT A RETROSPECTIVE REVIEW WAS CONDUCTED OF PREVIOUS STUDIES THAT INVESTIGATED THE SAFETY AND EFFICACY OF WATER VAPOR THERAPY PROCEDURES FOR PATIENTS WITH LOWER URINARY TRACT SYMPTOMS (LUTS). THE PURPOSE OF THIS REVIEW WAS TO COMPARE THE SAFETY AND EFFICACY BETWEEN PROSTATIC URETHRAL LIFT (PUL), WATER VAPOR THERMAL THERAPY (WVTT) AND TEMPORARY IMPLANTABLE NITINOL DEVICE (TIND). THERE WERE A TOTAL OF SIX STUDIES REVIEWED THAT DISCUSSED WATER VAPOR THERAPY. THE FIRST STUDY REVIEWED OUTLINED THE RESULTS OF WVTT PROCEDURES IN 62 PATIENTS AND REPORTED THE FOLLOWING COMPLICATIONS: 2.1% OF PATIENTS REQUIRED RETREATMENT DUE TO PERSISTENT SYMPTOMS. THE SECOND STUDY REVIEWED OUTLINED THE RESULTS OF WVTT IN 135 PATIENTS AND REPORTED THE FOLLOWING COMPLICATIONS: 0.7% EXPERIENCED URINARY RETENTION, 0.7% EXPERIENCED NAUSEA AND VOMITING THAT REQUIRED HOSPITALIZATION, ONE PATIENT DEVELOPED SEPSIS, 2.9% REPORTED EJACULATORY DYSFUNCTION, AND 4.4% OF THE PATIENTS REQUIRED RETREATMENT DUE TO PERSISTENT SYMPTOMS. THE THIRD STUDY REVIEWED OUTLINED THE RESULTS OF WVTT IN 53 PATIENTS AND REPORTED THE FOLLOWING COMPLICATIONS: 1.9% REPORTED BLADDER STONES AND BLADDER NECK CONTRACTURE, 1.9% REPORTED UROSEPSIS, AND 5.7% REQUIRED RETREATMENT DUE TO PERSISTENT SYMPTOMS. THE FOURTH STUDY REVIEWED OUTLINED THE RESULTS OF WVTT IN 129 PATIENTS AND REPORTED THE FOLLOWING COMPLICATIONS: 0.8% REPORTED BLADDER STONES, 0.8% REPORTED BLADDER NECK CONTRACTURE, 3.9% REPORTED URETHRAL STRICTURE, 3.1% REPORTED ERECTILE DYSFUNCTION, 3.1% REPORTED EJACULATORY DYSFUNCTION, 7.8% REQUIRED CYSTOSCOPIC LUTS EVALUATION, AND 2.3% REQUIRED RETREATMENT DUE TO PERSISTENT SYMPTOMS. THE FIFTH STUDY REVIEWED OUTLINED THE RESULTS OF WVTT IN 131 PATIENTS AND REPORTED THE FOLLOWING COMPLICATIONS: 3.1% REQUIRED RETREATMENT DUE TO PERSISTENT SYMPTOMS. THE FINAL STUDY REVIEWED OUTLINE THE RESULTS OF WVTT IN 65 PATIENTS AND REPORTED THE FOLLOWING COMPLICATIONS: 1.5% REPORTED PERSISTENT LUTS RELATED TO THE DEVICE/PROCEDURE, 10.8% REPORTED EJACULATORY DYSFUNCTION, AND 1.5% OF PATIENTS REQUIRED RETREATMENT DUE TO PERSISTENT SYMPTOMS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN EUROPEAN UROLOGY FOCUS THAT A RETROSPECTIVE REVIEW WAS CONDUCTED OF PREVIOUS STUDIES THAT INVESTIGATED THE SAFETY AND EFFICACY OF WATER VAPOR THERAPY PROCEDURES FOR PATIENTS WITH LOWER URINARY TRACT SYMPTOMS (LUTS). THE PURPOSE OF THIS REVIEW WAS TO COMPARE THE SAFETY AND EFFICACY BETWEEN PROSTATIC URETHRAL LIFT (PUL), WATER VAPOR THERMAL THERAPY (WVTT) AND TEMPORARY IMPLANTABLE NITINOL DEVICE (TIND). THERE WERE A TOTAL OF SIX STUDIES REVIEWED THAT DISCUSSED WATER VAPOR THERAPY. THE FIRST STUDY REVIEWED OUTLINED THE RESULTS OF WVTT PROCEDURES IN 62 PATIENTS AND REPORTED THE FOLLOWING COMPLICATIONS: 2.1% OF PATIENTS REQUIRED RETREATMENT DUE TO PERSISTENT SYMPTOMS. THE SECOND STUDY REVIEWED OUTLINED THE RESULTS OF WVTT IN 135 PATIENTS AND REPORTED THE FOLLOWING COMPLICATIONS: 0.7% EXPERIENCED URINARY RETENTION, 0.7% EXPERIENCED NAUSEA AND VOMITING THAT REQUIRED HOSPITALIZATION, ONE PATIENT DEVELOPED SEPSIS, 2.9% REPORTED EJACULATORY DYSFUNCTION, AND 4.4% OF THE PATIENTS REQUIRED RETREATMENT DUE TO PERSISTENT SYMPTOMS. THE THIRD STUDY REVIEWED OUTLINED THE RESULTS OF WVTT IN 53 PATIENTS AND REPORTED THE FOLLOWING COMPLICATIONS: 1.9% REPORTED BLADDER STONES AND BLADDER NECK CONTRACTURE, 1.9% REPORTED UROSEPSIS, AND 5.7% REQUIRED RETREATMENT DUE TO PERSISTENT SYMPTOMS. THE FOURTH STUDY REVIEWED OUTLINED THE RESULTS OF WVTT IN 129 PATIENTS AND REPORTED THE FOLLOWING COMPLICATIONS: 0.8% REPORTED BLADDER STONES, 0.8% REPORTED BLADDER NECK CONTRACTURE, 3.9% REPORTED URETHRAL STRICTURE, 3.1% REPORTED ERECTILE DYSFUNCTION, 3.1% REPORTED EJACULATORY DYSFUNCTION, 7.8% REQUIRED CYSTOSCOPIC LUTS EVALUATION, AND 2.3% REQUIRED RETREATMENT DUE TO PERSISTENT SYMPTOMS. THE FIFTH STUDY REVIEWED OUTLINED THE RESULTS OF WVTT IN 131 PATIENTS AND REPORTED THE FOLLOWING COMPLICATIONS: 3.1% REQUIRED RETREATMENT DUE TO PERSISTENT SYMPTOMS. THE FINAL STUDY REVIEWED OUTLINE THE RESULTS OF WVTT IN 65 PATIENTS AND REPORTED THE FOLLOWING COMPLICATIONS: 1.5% REPORTED PERSISTENT LUTS RELATED TO THE DEVICE/PROCEDURE, 10.8% REPORTED EJACULATORY DYSFUNCTION, AND 1.5% OF PATIENTS REQUIRED RETREATMENT DUE TO PERSISTENT SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404861 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

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