BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 24912523 · Received April 17, 2026

    Report

    Report Number
    2124215-2026-20938
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    January 23, 2026
    Report Date
    April 17, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHIRAMIZU, S., HIROAKI, S., TSUBONUMA, Y., KIMURO, R., HIGASHIJIMA, K., ARAMAKI, K., & FUJIMOTO, N. (2026). A RARE CASE OF RECURRENT DELAYED MASSIVE HEMATURIA DUE TO ARTERIAL BLEEDING FOLLOWING WATER VAPOR ENERGY THERAPY FOR BENIGN PROSTATIC HYPERPLASIA. CUREUS, 18(1), E102124. HTTPS://DOI.ORG/10.7759/CUREUS.102124

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LITERATURE ARTICLE, THAT A 77-YEAR-OLD MALE PATIENT WITH BENIGN PROSTATIC HYPERPLASIA (BPH) UNDERWENT A REZUM WATER VAPOR ENERGY THERAPY (WAVE) PROCEDURE. THE INITIAL POSTOPERATIVE COURSE WAS UNEVENTFUL; HOWEVER, ON POSTOPERATIVE DAY 7, THE PATIENT DEVELOPED BLADDER TAMPONADE DUE TO HEMATURIA, WHICH REQUIRED CLOT EVACUATION VIA BLADDER IRRIGATION. ON POSTOPERATIVE DAY 21, FOLLOWING CATHETER REMOVAL, THE PATIENT EXPERIENCED ACUTE URINARY RETENTION, HYPOTENSION, AND RECURRENT GROSS HEMATURIA. UPON READMISSION, THE PATIENT DEVELOPED RAPIDLY PROGRESSIVE ANEMIA. A FOLEY CATHETER WAS INSERTED, DRAINING BRIGHT RED URINE WHICH THE PHYSICIANS SUSPECTED WAS DUE TO ARTERIAL BLEEDING. AN EMERGENT CYSTOSCOPY WAS PERFORMED WHICH REVEALED A LARGE VOLUME OF CLOTS, BUT NO ACTIVE BLEEDING WAS DETECTED. THE FOLLOWING DAY, RECURRENT GROSS HEMATURIA OCCURRED. CONTRAST-ENHANCED CT IN THE ARTERIAL PHASE DEMONSTRATED CONTRAST EXTRAVASATION FROM THE BLADDER NECK. THE PATIENT WAS THEN GIVEN FOUR UNITS OF PACKED RED BLOOD CELLS AND FRESH FROZEN PLASMA. A REPEAT CYSTOSCOPY WAS PERFORMED WHICH CONFIRMED A BRIGHT RED CLOT WHICH WAS BELIEVED TO BE OF ARTERIAL ORIGIN EXTENDING FROM THE BLADDER NECK TO THE BLADDER CAVITY. ONCE THE CLOT WAS REMOVED, ACTIVE ARTERIAL HEMORRHAGE WAS OBSERVED IN THE PROSTATIC MEDIAN LOBE TOWARD THE BLADDER LUMEN. ELECTROCAUTERY WAS APPLIED AND COMPLETE HEMOSTASIS WAS ACHIEVED. THE PATIENT RECOVERED WITHOUT FURTHER RECURRENCE OF HEMATURIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968121 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| O| H