MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Hematuria (2558); Dysuria (2684); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

The exact event date is unknown. The date reflected is based on an approximate 6 weeks from the patient's report to bsc and applying the internal guidance. (b)(6).

Event Description

Boston scientific became aware of a patient experience with rezum on (b)(6) 2021. The patient reported that he underwent a water vapor therapy procedure approximately 6 weeks ago, and to date, the patient is unable to urinate most time of the day without extreme pain. The patient ended up with a catheter for almost two weeks and made two trips to the local emergency room; the first time was due to being unable to urinate at all and the second time was due to extreme pain when urinating. Even after 6 weeks post water vapor therapy procedure, the patient is still experiencing some bleeding with urination. For the first time since the water vapor therapy procedure, the patient had intercourse and reported that his orgasm, while painful, was also dry. The patient also recently developed epididymitis and was prescribed antibiotic that resulted in hives. The patient acknowledges that his condition may be unusual, but he believes boston scientific (bsc) literature does not advise adequately regarding the risks and complications that can result from water vapor therapy procedure. The patient does not know when he can expect to begin to feel better but he does know that the past 6 weeks have been a very negative life changing experience.

• 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 ; 4089353452
• MDR Report Key: 13028623
• MDR Text Key: 282483462
• Report Number: 2124215-2021-38247
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2021
• 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 Treatment Data

Date Received: 12/17/2021 Patient Sequence Number: 1