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); Discomfort (2330); Insufficient Information (4580)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

Date of event (b3) -the date of the event was not specified when the event was reported.

Event Description

It was reported via social media, that the patient experienced five times more frequency after the first water vapor therapy procedure.Now, the patient is experiencing ten times more urgency and tension within the first month.No further information was provided.

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.Date of event(b3)-the date of the event was not specified when the event was reported.

Event Description

It was reported via social media, that the patient experienced five times more frequency after the first water vapor therapy procedure.Now, the patient is experiencing ten times more urgency and tension within the first month.No further information was provided.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17691966
• MDR Text Key: 322752158
• Report Number: 2124215-2023-48172
• 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: 10/05/2023

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: 08/30/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 10/05/2023
• 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 Number: 1
• Patient Outcome(s): Other