BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 14887206 · Received July 1, 2022

    Report

    Report Number
    2124215-2022-23695
    Event Type
    Injury
    Date Received
    July 1, 2022
    Date of Event
    March 1, 2017
    Report Date
    July 1, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHITING, DANIEL: NOURELDIN, MOHAMED: ABDELMOTAGLY, YEHIA: JOHNSTON, MAXIMILIAN J.: BRITTAIN, JAMES: RAJKUMAR, GOVINDARAJ: EMARA, AMR: HINDLEY, RICHARD. "REAL-WORLD EARLY OUTCOMES AND RETREATMENT RATES FOLLOWING WATER VAPOUR ABLATIVE THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA." EUROPEAN UROLOGY OPEN SCIENCE 39 (2022): 72-78.HTTPS://DOI.ORG/10.1016/J.EUROS.2022.03.006. THERE WAS NO DEVICE PERFORMANCE ALLEGATION DURING TREATMENT. THE REPORTED PATIENT SYMPTOM IS A RISK ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA PROCEDURE. 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 THE EUROPEAN UROLOGY OPEN SCIENCE JOURNAL THE RESULTS OF THE FOLLOWING STUDY. THE ARTICLE DETAILED THE RETREATMENT RATES OF PATIENTS THAT UNDERWENT REZUM WATER VAPOR THERAPY PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA BETWEEN MARCH 2017 AND JANUARY 2020 AT TWO HOSPITAL SITES. A TOTAL OF 461 MALE PATIENTS THAT UNDERWENT REZUM TREATMENT WERE ANALYZED FOR FOLLOW UP POST-TREATMENT. THE STUDY SHOWED THAT THERE WAS A SIGNIFICANT IMPROVEMENT IN MEAN MAXIMUM FLOW RATE AND POSTVOID RESIDUAL VOLUME AND IN INTERNATIONAL PROSTATE SYMPTOM SCORE AND QUALITY-OF-LIFE. DURING THE FOLLOW-UP PERIOD, 21 PATIENTS (4.6%) REQUIRED RETREATMENT, OF WHICH 11 CASES (2.4%) WERE WITHIN THE FIRST YEAR. THE RETREATMENTS INCLUDED EIGHT BLADDER NECK INCISIONS OR RESECTIONS, SIX TRANSURETHRAL RESECTIONS OF THE PROSTATE, FOUR GREENLIGHT LASER PHOTO-SELECTIVE VAPORIZATIONS OF THE PROSTATE, AND THREE REZUM PROCEDURES. THE MOST COMMON FINDINGS AT RETREATMENT WERE AN INADEQUATELY TREATED MEDIAN LOBE, AN OBSTRUCTED BLADDER NECK, AND IN SOME CASES ASYMMETRY OF THE PROSTATE CAVITY OF RECESSES WITHIN THE PROSTATE GLAND. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE PER PATIENT OR FACILITY DATA FROM THE ARTICLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR FINDING OF OBSTRUCTED BLADDER NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206076 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| R