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); Insufficient Information (4580)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported by the patient via social media that the rezum water vapor therapy procedure did not work and urinary urgency symptom is the same as prior to the procedure.The patient also indicated of now having a distorted urinary stream.The patient has had to double his flomax (unknown dose) medication to two times a day.No further information was provided.

Event Description

It was reported by the patient via social media that the rezum water vapor therapy procedure did not work for him that his urinary urgency remains the same as prior to the procedure.The patient also indicated he now has a distorted urinary stream.The patient reported that he has had to double his current dose (amount unknown) of flomax and is now taking it twice daily.

Manufacturer Narrative

The delivery device was not returned for analysis and there was no report of a device performance allegation during treatment.The reported patient symptom of urinary urgency is a known risk associated with water vapor therapy procedures and is noted as such in the device instructions for use.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: 14519689
• MDR Text Key: 292787741
• Report Number: 2124215-2022-18233
• 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: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• 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 Received: 06/02/2022
• 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 Number: 1
• Patient Outcome(s): Other