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	Calcium Deposits/Calcification (1758); Micturition Urgency (1871); Unspecified Tissue Injury (4559)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific via a conference abstract that a study was conducted to investigate postoperative morphological changes and intraprostatic vapor distribution following water vapor energy therapy (wave) for benign prostatic hyperplasia (bph) using cystoscopy.The study included 42 patients who underwent wave by a single surgeon between (b)(6) 2024 and (b)(6) 2025, with 9 patients analyzed after undergoing cystoscopy 3-6 months postoperatively due to questionable symptom improvement after wave.Patient age ranged from 75 to 83 years, prostate volume ranged from 30 to 54 ml, and one to two punctures per lobe were performed.Cystoscopic findings and symptom scores, including international prostate symptom score (ipss), ipss-quality of life (ipss-qol), and overactive bladder symptom score (oabss), were evaluated.Cystoscopy revealed heterogeneous vapor spread in several cases, and in one patient, vapor unexpectedly extended through the ejaculatory duct, causing mucosal whitening and cavity formation.Additional findings obtained during conference attendance indicated that one case involved calculus formation, four cases showed insufficient improvement of lower urinary tract symptoms (luts), and two cases underwent reoperation using aquablation.One patient experienced difficult catheterization, while persistent storage symptoms occurred in other patients.In some cases where uneven reduction in prostate size was observed after wave, it was suspected that water vapor may have been delivered into the vas deferens/ejaculatory duct within the prostate; however, no detailed information was obtained.

• 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: 25261864
• Report Number: 2124215-2026-27834
• Device Sequence Number: 5496365
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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: 06/16/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 07/09/2026
• 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: Other; Hospitalization
• Patient Sex: Unknown