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 Micturition Urgency (1871); Unspecified Infection (1930); Urinary Retention (2119); Obstruction/Occlusion (2422); Dysuria (2684); Urinary Incontinence (4572)

Event Date 05/01/2022

Event Type  Injury  

Event Description

It was reported that following a water vapor thermal therapy procedure, the patient was not satisfied.The patient had been catheterized for longer than expected and experienced a slow and painful urination.The patient indicated being prescribed with three different antibiotics.Then, the patient experienced incontinence leading to an endoscopy being performed which revealed some tissue partially blocking the urethra.Three months after the procedure, the patient still experienced urinary urgency.No additional information was reported.

Event Description

It was reported that following a water vapor thermal therapy procedure, the patient was not satisfied.The patient had been catheterized for longer than expected and experienced a slow and painful urination.The patient indicated being prescribed with three different antibiotics.Then, the patient experienced incontinence leading to an endoscopy being performed which revealed some tissue partially blocking the urethra.Three months after the procedure, the patient still experienced urinary urgency.No additional information was reported.

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 of urinary retention, dysuria, infection, incontinence, obstruction, and urinary urgency are known risks associated with the use of these devices 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.

• 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 Key: 15365617
• MDR Text Key: 299332567
• Report Number: 2124215-2022-34365
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male