REZUM
Report
- Report Number
- 2124215-2024-66291
- Event Type
- Injury
- Date Received
- November 1, 2024
- Date of Event
- September 1, 2021
- Report Date
- January 2, 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
BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, 09/01/2021, WAS CHOSEN AS THE BEST ESTIMATE BASED ON YEAR THE ARTICLE WAS PUBLISHED. BLOCK G2: LITERATURE SOURCE: MCVARY, K ET AL (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. THE JOURNAL OF UROLOGY. VOL 206, P.P. 715-724. 0022-5347/21/2063-0716/0.
THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE ALLEGATION. THE REPORTED PATIENT'S SYMPTOMS ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE (IFU) BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, 09/01/2021, WAS CHOSEN AS THE BEST ESTIMATE BASED ON YEAR THE ARTICLE WAS PUBLISHED. BLOCK G2: LITERATURE SOURCE MCVARY, K ET AL (2021). FINAL 5 - YEAR OUTCOMES OF THE MULTICENTER RANDOMIZED SHAM - CONTROLLED TRIAL OF A WATER VAPOR THERMAL THERAPY FOR TREATMENT OF MODERATETO SEVERE LOWER URINARY TRACT SYMPTOMS SECONDARY TO BENIGN PROSTATIC HYPERPLASIA. THE JOURNAL OF UROLOGY. VOL 206, P.P. 715-724. 0022-5347/21/2063-0716/0.
IT WAS REPORTED TO BOSTON SCIENTIFIC AN ARTICLE PUBLISHED IN THE JOURNAL OF UROLOGY, THAT A MULTICENTER STUDY WAS CONDUCTED AT 15 CENTERS IN THE UNITED STATES, WITH A FOLLOW UP PERIOD OF 5 YEARS. THE DATA OF 197 PATIENTS UNDERWENT VAPOR TREATMENTS, ONLY THE DATA FROM 77 SUBJECTS WERE ANALYZED. THE MOST COMMON ADVERSE EVENTS RELATED TO DEVICE OR PROCEDURE WERE DYSURIA, GROSS HEMATURIA, HEMATOSPERMIA, URINARY FREQUENCY, ACUTE URINARY RETENTION, UNCONFIRMED URINARY TRACT INFECTION, AND DECREASED IN EJACULATORY VOLUME. THESE ADVERSE EVENTS RESOLVED EITHER SPONTANEOUSLY OR WITH ROUTINE TREATMENT. NO ADVERSE EVENTS OCCURRED FROM YEARS 1 TO 5. DURING THE TIME OF THIS STUDY, 11.1% SUBJECTS OF THE TREATMENT ARM REQUIRED BPH MEDICATION AND 4.4% OF THE SUBJECTS REQUIRED SURGICAL RE-TREATMENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC AN ARTICLE PUBLISHED IN THE JOURNAL OF UROLOGY, THAT A MULTICENTER STUDY WAS CONDUCTED AT 15 CENTERS IN THE UNITED STATES, WITH A FOLLOW UP PERIOD OF 5 YEARS. THE DATA OF 197 PATIENTS UNDERWENT VAPOR TREATMENTS, ONLY THE DATA FROM 77 SUBJECTS WERE ANALYZED. THE MOST COMMON ADVERSE EVENTS RELATED TO DEVICE OR PROCEDURE WERE DYSURIA, GROSS HEMATURIA, HEMATOSPERMIA, URINARY FREQUENCY, ACUTE URINARY RETENTION, UNCONFIRMED URINARY TRACT INFECTION, AND DECREASED IN EJACULATORY VOLUME. THESE ADVERSE EVENTS RESOLVED EITHER SPONTANEOUSLY OR WITH ROUTINE TREATMENT. NO ADVERSE EVENTS OCCURRED FROM YEARS 1 TO 5. DURING THE TIME OF THIS STUDY, 11.1% SUBJECTS OF THE TREATMENT ARM REQUIRED BPH MEDICATION AND 4.4% OF THE SUBJECTS REQUIRED SURGICAL RE-TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631524 | REZUM | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |