MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Rezum; Unit, Electrosurgical Endoscopic (With Or Without Accessories)

Model Number	M006D2201-0032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Frequency / Polyuria (2275)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had water vapor energy therapy performed on (b)(6) 2023 with no device malfunctions or any serious adverse events.Six injections were performed on the right and left lobe, and 1 injection was on the middle lobe with minor bleeding in each case.On (b)(6) 2026 the patient visited the hospital for a follow up after three years.During the visit it was confirmed that there were new or worsening lower urinary tract symptoms and the patient was re-treated with the rezum device.The procedure was completed with the rezum device; however, a patient outcome was not reported.
Event or Problem Description
It was reported that on (b)(6) 2023, a water vapor energy therapy was performed, and the procedure was completed without any device malfunction or serious adverse event.There were 6 injections were performed on the right and left lobe and 1 injection on the middle lobe with minor bleeding in each case.On (b)(6) 2026, a patient visited the hospital for a follow up after 3 years.It was confirmed that there were new or worsening lower urinary tract symptoms, and the patient received re-treatment with rezum.The procedure was completed with this device.The patient outcome information was not reported.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.The reported patient symptoms are a known risk associated with this device type as indicated in the instructions for use.Risk review was completed and confirmed that the event of urinary frequency was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Based on the reported clinical observations and investigational findings, the probable cause for this event was determined to be adverse event related to procedure.There are procedural-related factors that may have contributed to the observed issue including treatment with rezum delivery device, leading to the reported allegations, which according to the instructions for use and hazard analysis documentation are all adverse events related to device or procedure following active treatment with rezum.Based on the information available, a conclusion code of adverse event related to procedure was assigned to this investigation.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The reported patient symptom(s) are known risk associated with this device type and indicated as such in the instructions for use.

• Brand Name: Rezum
• Common Device Name: 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; 4100 hamline avenue north; saint paul MN 55112 -579
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50130948
• Report Number: 2124215-2026-41708
• Device Sequence Number: 10513868
• Product Code: KNS
• UDI-Device Identifier: 00191506006785
• UDI-Public: (01)00191506006785(17)250326(10)31483636
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2025
• Device Model Number: M006D2201-0032
• Device Catalogue Number: M006D2201-0032
• Device Lot Number: 0031483636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2026
• Supplement Date Received by Manufacturer: 07/30/2026; Not provided
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 08/17/2026; 09/04/2026
• Date Device Manufactured: 04/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Generator: G2200-0034 SN: (b)(6).; Generator: G2200-0034 SN: (b)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 118 LB