REZUM
Report
- Report Number
- 2124215-2025-55588
- Event Type
- Injury
- Date Received
- August 28, 2025
- Date of Event
- January 1, 2013
- Report Date
- September 23, 2025
- 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
THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. THE REPORTED PATIENT SYMPTOMS ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. MCVARY, K. T., ROGERS, T., AND ROEHRBORN, C. G. (2019). REZUM WATER VAPOR THERMAL THERAPY FOR LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA: 4-YEAR RESULTS FROM RANDOMIZED CONTROLLED STUDY. UROLOGY, 126, 171-179. HTTPS://DOI.ORG/10.1016/J.UROLOGY.2018.12.041 B3. DATE OF EVENT THE EXACT DATE OF THE EVENT IS UNKNOWN, ESTIMATED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
MCVARY, K. T., ROGERS, T., AND ROEHRBORN, C. G. (2019). REZUM WATER VAPOR THERMAL THERAPY FOR LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA: 4-YEAR RESULTS FROM RANDOMIZED CONTROLLED STUDY. UROLOGY, 126, 171-179. HTTPS://DOI.ORG/10.1016/J.UROLOGY.2018.12.041. B3. DATE OF EVENT THE EXACT DATE OF THE EVENT IS UNKNOWN, ESTIMATED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN PROSTATIC DISEASES AND MALE VOIDING DYSFUNCTION, THAT A PROSPECTIVE, MULTICENTER, DOUBLE-BLIND RANDOMIZED CONTROLLED STUDY WAS CONDUCTED ON PATIENTS TREATED WITH REZUM AND FOLLOWED ANNUALLY FOR 4 YEARS SINCE 2013 OR 2014. A TOTAL OF 197 PATIENTS WERE INCLUDED AND RANDOMLY ASSIGNED 136 PATIENTS TO WATER VAPOR THERMAL THERAPY AND 61 TO SHAM/CONTROL PROCEDURE. ALL PROCEDURES WERE SUCCESSFULLY PERFORMED WITHOUT PERIOPERATIVE DEVICE OR PROCEDURE-RELATED ADVERSE EVENTS. REGARDING NON-SERIOUS ADVERSE EVENTS, THE PATIENTS EXPERIENCED DYSURIA, HEMATURIA, FREQUENCY AND URGENCY, ACUTE URINARY RETENTION AND URINARY TRACT INFECTION SUSPECTED. ALL THE CASES WERE TREATED ROUTINELY OR RESOLVED WITHOUT TREATMENT WITHIN 3 WEEKS. ALSO, ONE PATIENT HAD A BLADDER NECK CONTRACTURE AND BLADDER CALCULI 6 MONTHS POST PROCEDURE. ANOTHER PATIENT PRESENTED UROSEPSIS. AFTER 4 YEARS, SURGICAL INTERVENTION WAS PERFORMED IN 6 PATIENTS AND 7 PATIENTS-INITIATED USE OF ALPHA BLOCKERS WITHIN 4 YEARS OF FOLLOW UP. OVER A FOUR-YEAR FOLLOW-UP PERIOD, WATER VAPOR THERMAL THERAPY DEMONSTRATED SIGNIFICANT AND SUSTAINED IMPROVEMENTS IN URINARY SYMPTOMS AND FLOW RATES. THE MEAN INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS) SCORES SHOWED CONSISTENT REDUCTIONS FROM BASELINE. URINARY FLOW RATE (QMAX) IMPROVEMENTS REMAINED SIGNIFICANT, THOUGH SLIGHTLY REDUCED OVER TIME, FROM AN AVERAGE INCREASE. PATIENTS WITH MEDIAN LOBE ENLARGEMENT EXPERIENCED SIMILAR BENEFITS TO THOSE WITHOUT. BOTH MODERATE AND SEVERE LOWER URINARY TRACT SYMPTOMS (LUTS) PATIENTS SHOWED COMPARABLE SYMPTOM RELIEF, WITH IPSS IMPROVEMENTS. QUALITY OF LIFE AND BPH IMPACT INDEX SCORES REMAINED SIGNIFICANTLY IMPROVED, AND CROSSOVER SUBJECTS SHOWED SIMILAR IMPROVEMENT PATTERNS TO THE ORIGINAL TREATMENT GROUP OVER THREE YEARS.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN PROSTATIC DISEASES AND MALE VOIDING DYSFUNCTION, THAT A PROSPECTIVE, MULTICENTER, DOUBLE-BLIND RANDOMIZED CONTROLLED STUDY WAS CONDUCTED ON PATIENTS TREATED WITH REZUM AND FOLLOWED ANNUALLY FOR 4 YEARS SINCE 2013 OR 2014. A TOTAL OF 197 PATIENTS WERE INCLUDED AND RANDOMLY ASSIGNED 136 PATIENTS TO WATER VAPOR THERMAL THERAPY AND 61 TO SHAM/CONTROL PROCEDURE. ALL PROCEDURES WERE SUCCESSFULLY PERFORMED WITHOUT PERIOPERATIVE DEVICE OR PROCEDURE-RELATED ADVERSE EVENTS. REGARDING NON-SERIOUS ADVERSE EVENTS, THE PATIENTS EXPERIENCED DYSURIA, HEMATURIA, FREQUENCY AND URGENCY, ACUTE URINARY RETENTION AND URINARY TRACT INFECTION SUSPECTED. ALL THE CASES WERE TREATED ROUTINELY OR RESOLVED WITHOUT TREATMENT WITHIN 3 WEEKS. ALSO, ONE PATIENT HAD A BLADDER NECK CONTRACTURE AND BLADDER CALCULI 6 MONTHS POST PROCEDURE. ANOTHER PATIENT PRESENTED UROSEPSIS. AFTER 4 YEARS, SURGICAL INTERVENTION WAS PERFORMED IN 6 PATIENTS AND 7 PATIENTS-INITIATED USE OF ALPHA BLOCKERS WITHIN 4 YEARS OF FOLLOW UP. OVER A FOUR-YEAR FOLLOW-UP PERIOD, WATER VAPOR THERMAL THERAPY DEMONSTRATED SIGNIFICANT AND SUSTAINED IMPROVEMENTS IN URINARY SYMPTOMS AND FLOW RATES. THE MEAN INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS) SCORES SHOWED CONSISTENT REDUCTIONS FROM BASELINE. URINARY FLOW RATE (QMAX) IMPROVEMENTS REMAINED SIGNIFICANT, THOUGH SLIGHTLY REDUCED OVER TIME, FROM AN AVERAGE INCREASE. PATIENTS WITH MEDIAN LOBE ENLARGEMENT EXPERIENCED SIMILAR BENEFITS TO THOSE WITHOUT. BOTH MODERATE AND SEVERE LOWER URINARY TRACT SYMPTOMS (LUTS) PATIENTS SHOWED COMPARABLE SYMPTOM RELIEF, WITH IPSS IMPROVEMENTS. QUALITY OF LIFE AND BPH IMPACT INDEX SCORES REMAINED SIGNIFICANTLY IMPROVED, AND CROSSOVER SUBJECTS SHOWED SIMILAR IMPROVEMENT PATTERNS TO THE ORIGINAL TREATMENT GROUP OVER THREE YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 247131 | REZUM | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| O |