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 Codes	Micturition Urgency (1871); Stenosis (2263)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(2026).Surgical intervention for voiding dysfunction after water vapor thermal therapy: 3 cases from our institution.Op-0540-03.
Event or Problem Description
It was reported to boston scientific via an article presented on the 133rd annual meeting of the japanese urological association, that a retrospective study was conducted to assess required re-operation, after a water vapor thermal therapy procedure using rezum to treat benign prostatic hyperplasia.Data from patients that underwent rezum therapy from 01june2024 to 30july2025 at 1 institution in japan indicated that 3 patients required re-operation.Case 2 was a 70s male who underwent rezum therapy.However, his voiding dysfunction persisted.Cystoscopy revealed a bladder neck contracture.This patient underwent transurethral resection, which improved the patient's subjective feeling, urinary flow did not improve significantly.This suggested that the patient had a concurrent neurogenic bladder.

• 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 ave. n.; st. paul MN 55112
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25260030
• Report Number: 2124215-2026-27785
• Device Sequence Number: 18777067
• Product Code: KNS
• UDI-Device Identifier: 00191506006785
• UDI-Public: (01)00191506006785
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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 Model Number: M006D2201-0032
• Device Catalogue Number: M006D2201-0032
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 07/06/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male