BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 20625740 · Received November 6, 2024

    Report

    Report Number
    2124215-2024-70000
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    March 21, 2021
    Report Date
    November 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GIAMPAOLO SIENA, L. CINDOLO, G. FERRARI, D. MARUZZI, G. FASOLIS, S.V. CONDORELLI, F. VARVELLO, F. VISALLI, S. RABITO, S. TOSO, S. CAROASSAI, A. MARI, L. VIOLA, B.K. SMOANI, AND M. CARINI. WATER VAPOR THERAPY (REZUM) FOR LOWER URINARY TRACT SYMPTOMS RELATED TO BENIGN PROSTATIC HYPERPLASIA: EARLY RESULTS FROM THE FIRST ITALIAN MULTICENTRIC STUDY. WORLD JOURNAL OF UROLOGY (2021) 39:3875-3880. HTTPS://DOI.ORG/10.1007/S00345-021-03642-4.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF UROLOGY THAT A PROSPECTIVE STUDY WAS CONDUCTED TO ASSESS THE OUTCOMES OF PATIENTS TREATED WITH REZUM WATER VAPOR THERAPY PROCEDURE TO TREAT BENIGN PROSTATIC HYPERPLASIA. A TOTAL OF 135 PATIENTS WERE TREATED WITH REZUM BETWEEN JUNE 2019 AND AUGUST 2020 AT ONE OF 5 INSTITUTIONS IN ITALY. FOLLOWING THE PROCEDURES, THE FOLLOWING COMPLICATIONS WERE REPORTED: MILD HEMATURIA, HEMATOSPERMIA, DYSURIA, 8 PATIENTS HAD URINARY TRACT INFECTIONS, AND 16 PATIENTS HAD ACUTE URINARY RETENTION (AUR). THE 8 PATIENTS WHO HAD A URINARY TRACT INFECTION WERE TREATED WITH ANTIBIOTICS. OF THE 16 PATIENTS WHO HAD AUR, ALL EXCEPT 3 WERE SUCCESSFULLY TREATED WITH CATHETERIZATION. THE 3 REMAINING PATIENTS UNDERWENT TRANSURETHRAL RESECTION OF THE PROSTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416807 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R