BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 23916947 · Received December 29, 2025

    Report

    Report Number
    2124215-2025-93430
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    December 8, 2025
    Report Date
    February 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. A REVIEW OF MANUFACTURING DOCUMENTATION WAS NOT PERFORMED AS THE LOT/BATCH NUMBER FOR THIS COMPONENT WAS NOT PROVIDED. THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. THE REPORTED PATIENT SYMPTOM(S) ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. B3. DATE OF EVENT THE EXACT DATE OF THE EVENT IS UNKNOWN, ESTIMATED. MCVARY, K. T., GITTELMAN, M. C., GOLDBERG, K. A., PATEL, K., SHORE, N. D., LEVIN, R. M., PLISKIN, M., BEAHRS, J. R., PRALL, D., KAMINETSKY, J., COWAN, B. E., CANTRILL, C. H., MYNDERSE, L. A., ULCHAKER, J. C., TADROS, N. N., GANGE, S. N., AND ROEHRBORN, C. G. (2021). FINAL 5-YEAR OUTCOMES OF THE MULTICENTER RANDOMIZED SHAM-CONTROLLED TRIAL OF A WATER VAPOR THERMAL THERAPY FOR TREATMENT OF MODERATE TO SEVERE LOWER URINARY TRACT SYMPTOMS SECONDARY TO BENIGN PROSTATIC HYPERPLASIA. JOURNAL OF UROLOGY, 206(3), 715-724. HTTPS://DOI.ORG/10.1097/JU.0000000000001778. 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 SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT THE EXACT DATE OF THE EVENT IS UNKNOWN, ESTIMATED. MCVARY, K. T., GITTELMAN, M. C., GOLDBERG, K. A., PATEL, K., SHORE, N. D., LEVIN, R. M., PLISKIN, M., BEAHRS, J. R., PRALL, D., KAMINETSKY, J., COWAN, B. E., CANTRILL, C. H., MYNDERSE, L. A., ULCHAKER, J. C., TADROS, N. N., GANGE, S. N., AND ROEHRBORN, C. G. (2021). FINAL 5-YEAR OUTCOMES OF THE MULTICENTER RANDOMIZED SHAM-CONTROLLED TRIAL OF A WATER VAPOR THERMAL THERAPY FOR TREATMENT OF MODERATE TO SEVERE LOWER URINARY TRACT SYMPTOMS SECONDARY TO BENIGN PROSTATIC HYPERPLASIA. JOURNAL OF UROLOGY, 206(3), 715-724. HTTPS://DOI.ORG/10.1097/JU.0000000000001778.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA A JOURNAL ARTICLE PUBLISHED IN JOURNAL OF UROLOGY, THAT A PIVOTAL STUDY WAS CONDUCTED ON PATIENTS TREATED WITH REZUM WITH A FOLLOW UP PERIOD OF 5 YEARS, TO EVALUATE THE TREATMENT OF MODERATE TO SEVERE LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA. A TOTAL OF 197 PATIENTS WERE INCLUDED, WHERE 136 PATIENTS WHERE IN TREATMENT ARM AND 61 TO THE CONTROL ARM. OUTCOME MEASURES, INCLUDING INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS), PEAK URINARY FLOW RATE (QMAX), POST-VOID RESIDUAL VOLUME, VOIDED VOLUME, AND PROSTATE SPECIFIC ANTIGEN (PSA), AND BY ADMINISTRATION OF THE IPSS, IPSS QUALITY OF LIFE (QOL) AND BPH IMPACT INDEX (BPHII) SURVEYS. REGARDING PATIENT COMPLICATIONS, BOTH GROUPS PRESENTED PATIENTS WITH DYSURIA, GROSS HEMATURIA, HEMATOSPERMIA, URINARY FREQUENCY AND ACUTE URINARY RETENTION, SUSPECTED URINARY TRACT INFECTION AND DECREASE IN EJACULATORY VOLUME. THE ADVERSE EVENT PRESENTED WERE MILD TO MODERATE IN SEVERITY AND RESOLVED EITHER SPONTANEOUSLY OR WITH ROUTINE TREATMENT. WATER VAPOR THERMAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA (BPH) IS DESCRIBED AS A MINIMALLY INVASIVE TREATMENT THAT OFFERS OUTCOMES COMPARABLE TO OTHER ABLATIVE THERAPIES WHILE PRESERVING SEXUAL FUNCTION. IT HAS A SHORT LEARNING CURVE, DOES NOT REQUIRE ADVANCED TECHNIQUES TO TREAT DIFFERENT PROSTATE ZONES, INCLUDING AN OBSTRUCTIVE MIDDLE LOBE AND DEMONSTRATES A FAVORABLE SAFETY PROFILE WITH LONG-TERM DURABILITY. THESE CHARACTERISTICS MAKE IT AN OPTIMAL OPTION FOR PATIENTS EXPERIENCING MODERATE TO SEVERE LOWER URINARY TRACT SYMPTOMS (LUTS).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA A JOURNAL ARTICLE PUBLISHED IN JOURNAL OF UROLOGY, THAT A PIVOTAL STUDY WAS CONDUCTED ON PATIENTS TREATED WITH REZUM WITH A FOLLOW UP PERIOD OF 5 YEARS, TO EVALUATE THE TREATMENT OF MODERATE TO SEVERE LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA. A TOTAL OF (B)(6) PATIENTS WERE INCLUDED, WHERE 136 PATIENTS WHERE IN TREATMENT ARM AND 61 TO THE CONTROL ARM. OUTCOME MEASURES, INCLUDING INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS), PEAK URINARY FLOW RATE (QMAX), POST-VOID RESIDUAL VOLUME, VOIDED VOLUME, AND PROSTATE SPECIFIC ANTIGEN (PSA), AND BY ADMINISTRATION OF THE IPSS, IPSS QUALITY OF LIFE (QOL) AND BPH IMPACT INDEX (BPHII) SURVEYS. REGARDING PATIENT COMPLICATIONS, BOTH GROUPS PRESENTED PATIENTS WITH DYSURIA, GROSS HEMATURIA, HEMATOSPERMIA, URINARY FREQUENCY AND ACUTE URINARY RETENTION, SUSPECTED URINARY TRACT INFECTION AND DECREASE IN EJACULATORY VOLUME. THE ADVERSE EVENT PRESENTED WERE MILD TO MODERATE IN SEVERITY AND RESOLVED EITHER SPONTANEOUSLY OR WITH ROUTINE TREATMENT. WATER VAPOR THERMAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA (BPH) IS DESCRIBED AS A MINIMALLY INVASIVE TREATMENT THAT OFFERS OUTCOMES COMPARABLE TO OTHER ABLATIVE THERAPIES WHILE PRESERVING SEXUAL FUNCTION. IT HAS A SHORT LEARNING CURVE, DOES NOT REQUIRE ADVANCED TECHNIQUES TO TREAT DIFFERENT PROSTATE ZONES, INCLUDING AN OBSTRUCTIVE MIDDLE LOBE AND DEMONSTRATES A FAVORABLE SAFETY PROFILE WITH LONG-TERM DURABILITY. THESE CHARACTERISTICS MAKE IT AN OPTIMAL OPTION FOR PATIENTS EXPERIENCING MODERATE TO SEVERE LOWER URINARY TRACT SYMPTOMS (LUTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2109968 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other