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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematuria (2558)
Event Date 01/01/2020
Event Type  Injury  
Event Description
It was reported to boston scientific via an article published in the authors bju international the results of the following study.The article discussed the results of 33 patients who underwent rezum water vapor therapy procedure for treatment of benign prostatic hyperplasia (bph) between january 2020 and july 2021.The study showed that the water vapor therapy treatment significantly improved international prostate symptom score and quality-of-life.Following the procedure, 9.1% of the patients reported transient dysuria.One patient required readmission for hematuria.Two patients (6%) had a post-operative urinary tract infection (uti).It was not possible to ascertain specific device per patient event or facility data from the article.No further information is available.This report is for the finding of readmission for hematuria.
 
Manufacturer Narrative
Related to mfr reports: 2124215-2022-25738 and 2124215-2022-25742 created from the same literature article.W lam, ch tam, s chum, jhl tsu, division of urology, department of surgery, queen mary hospital, hong kong sar; division of urology, department of surgery, lks faculty of medicine, the university of hong kong, hong kong sar."transurethral convective radiofrequency water vapour thermal therapy of the prostate (rezum) for men with lower urinary tract symptoms related to benign prostatic hyperplasia at a single institution: a pilot study and initial outcomes." bju international published by john wiley & sons ltd (2022): 129 supplement 1.4-22.
 
Manufacturer Narrative
There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.Related to mfr reports: 2124215-2022-25738 and 2124215-2022-25742 created from the same literature article.W lam, ch tam, s chum, jhl tsu, division of urology, department of surgery, queen mary hospital, hong kong sar; division of urology, department of surgery, lks faculty of medicine, the university of hong kong, hong kong sar."transurethral convective radiofrequency water vapour thermal therapy of the prostate (rezum) for men with lower urinary tract symptoms related to benign prostatic hyperplasia at a single institution: a pilot study and initial outcomes." bju international published by john wiley & sons ltd (2022): 129 supplement 1.4-22.
 
Event Description
It was reported to boston scientific via an article published in the authors bju international the results of the following study.The article discussed the results of 33 patients who underwent rezum water vapor therapy procedure for treatment of benign prostatic hyperplasia (bph) between january 2020 and july 2021.The study showed that the water vapor therapy treatment significantly improved international prostate symptom score and quality-of-life.Following the procedure, 9.1% of the patients reported transient dysuria.One patient required readmission for hematuria.Two patients (6%) had a post-operative urinary tract infection (uti).It was not possible to ascertain specific device per patient event or facility data from the article.No further information is available.This report is for the finding of readmission for hematuria.
 
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Brand Name
REZUM
Type of Device
UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
alyson harris
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key15028650
MDR Text Key295976155
Report Number2124215-2022-25732
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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