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U.S. Department of Health and Human Services


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Model Number D2201
Device Problem Use of Device Problem (1670)
Patient Problems Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); No Code Available (3191)
Event Date 03/27/2018
Event Type  Injury  
Event Description
Facts on (b)(6) 2018, in (b)(6), i was treated with the rezum system for benign prostatic hyperplasia by (b)(6), md. Following the procedure, i was told that i had received 15 rezum treatments which included every treatment site identified by the mfr. This number of treatments was far in excess of what is typical. Subsequently, i continued to bleed for approx 5 weeks. I also was treated, near the end of the 5 week period with multiple courses of antibiotics for a uti. This post-procedure experience was inconsistent with the recovery advertised by the mfr. Subsequently, i have learned that the procedure rendered me essentially anorgasmic. I have been advised that this is likely permanent. While i still ejaculate, that function causes significant pain and discomfort with subsequent urination. Recently i have had to periodically resume taking alpha-blockers, which, according to the clinical trial, is a very rare result. I am now receiving care from a new urologist. It is my opinion that i was significantly over-treated with the rezum system. The deficiencies in instructions, the instructions for use for the rezum device includes a precaution which provides: excessive treatments: treatments in excess of those recommended in the guidelines may lead to prolonged irritative symptoms and/or catheterization. This is the only statement that identifies a risk from excessive treatments. It is inadequate and misleading - a violation of 21 cfr 801. 5. Excessive treatments increase the possibility of adverse events and permanently poor outcomes. The clinical trial for the rezum system does not include any discussion of the risks of excessive treatments. Two aspects of the instructions are misleading and inadequate; 21 cfr 801. 5(b) and (c) acquire instructions for the use that take into account the different physical conditions of pts. Although the instructions appear to do this, overall, the instructions are deficient. The instructions do not established an overriding relationship between the total number of rezum treatments and the size of the pt's prostate. From personal experience, the mfr identifies 15 distinct sites for the rezum process, but the instructions suggest that 12 (or more) treatments can be administered if certain criteria exist. The process of estimation of the "prostatic treatment length" is not described in any detail. At best, the physician is guessing that the underlying tissue is hyperplasic tissue. The instructions, while appearing specific, are too vague to provide meaningful guidance to the user. This is particularly true for instructions 9 for treatment of the median lobe (". And two or more treatments if medial lobe is >2cm"). The instructions do not place any limit on the number of treatments to the median lobe. The absence of a limit on the number of treatments cannot lead to the safe and effective use of the device on the medial lobe. Each rezum treatment creates a 1. 5 to 2. 0 cm lesion. With 15 treatments, as much as 30 cc of prostate tissue may be removed. This might be appropriate for a 80 cc gland, but may not be at all appropriate for a 40 cc prostate. (the clinical trial treated no prostate larger than 58. 8 cc). Absent a precaution, the potential for over-treatment is substantial. The number of treatments provided for in the instructions are not supported by the evidence in the clinical trial. The clinical trial used a maximum of 8. 7 treatments on 136 test subjects. The instructions - apparently endorsed by the fda - allow for 12 or more treatments. The clinical trial fails to discuss any problems which may arise from overtreatment. The instructions do not require a determination of the appropriateness of the total number of treatments before treatment begins. The instructions may be followed sequentially without reference to the whole. This deficiency sets the stage for overtreatment. The fda should exercise the authority under 21 cfr 810 to recall the rezum system and require correction to the instructions for use to include: an overriding precaution statement that users relate the number of treatments to the size of the pt's prostate and that excessive treatments will substantially increase the potential for adverse incidents and permanent harm to the pt; that the instructions for use revise the ". And two or more treatments if medial lobe is >2 cm" language. This language creates immediate uncertainty and sets the stage for overtreatment to determine the total number before treatment commences, and reasons for that number. This requirement would provide protection against overtreatment. Recall of a medical device to require correction of inaccurate or misleading instructions has been ordered by the fda. See the cordis recall to revise instructions in 2004, z-0909-04. Two other matters: first, it is my general understanding that a rep of the mfr, either nxthera or boston scientific, may have been present during my procedure. Rezum was at that time being introduced into the (b)(6) market. Second, i reported my adverse experience with rezum to boston scientific in (b)(6) of 2019 via website portal. I received a request to provide info regarding the date of my procedure and the provider. This email indicated that my case would be "reviewed. " subsequently, i requested that boston scientific provide any info it may have or that it may be aware of relating to overtreatment with the system. Boston scientific responded, explaining that they are "unable to provide the requested info. " thus, they are unable to provide the info, not that the info does not exist. To protect pts and evaluate the risks and problems from overtreatment, the fda should obtain this info from the mfr. Fda safety report id# (b)(4).
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Manufacturer (Section D)
MDR Report Key8712316
MDR Text Key148745689
Report NumberMW5087451
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD2201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/18/2019 Patient Sequence Number: 1