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	Hematuria (2558)
Date of Event	07/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific via an article that a retrospective study conducted between july 2023 and june 2025 evaluated the safety and efficacy of transurethral water vapor energy therapy (wave) in patients with benign prostatic hyperplasia who also had prostate cancer.A total of 8 patients aged 66 to 83 years (median 75) were included from a larger cohort of 189 patients.Wave was performed for the treatment of benign prostatic hyperplasia and not for prostate cancer.One adverse event of transient hematuria with clots following catheter removal was reported in a patient receiving anticoagulant therapy who underwent concurrent biopsy.No device malfunctions were reported.
Event or Problem Description
It was reported to boston scientific via an article that a retrospective study conducted between july 2023 and june 2025 evaluated the safety and efficacy of transurethral water vapor energy therapy (wave) in patients with benign prostatic hyperplasia who also had prostate cancer.A total of 8 patients aged 66 to 83 years (median 75) were included from a larger cohort of 189 patients.Wave was performed for the treatment of benign prostatic hyperplasia and not for prostate cancer.One adverse event of transient hematuria with clots following catheter removal was reported in a patient receiving anticoagulant therapy who underwent concurrent biopsy.No device malfunctions were reported.
Additional Manufacturer Narrative
No additional information or visual evidence was available for review.The device was not returned; therefore, no product analysis could be performed and the reported event could not be confirmed.If the device is returned in the future, the investigation may be reopened.The risk review confirmed that hematuria is a known event and is documented within the product risk analysis as part of the acceptable risk profile.Labeling includes information identifying hematuria as a potential adverse event associated with the procedure.No device malfunction was reported.Based on the reported clinical information and investigation findings, the most probable root cause is an adverse event related to the procedure.Contributing factors may include procedural conditions such as concurrent biopsy and the use of anticoagulant therapy.No further action or escalation is required.

• 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; marlborough MN 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25260069
• Report Number: 2124215-2026-27801
• Device Sequence Number: 10512116
• 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): 06/22/2026

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: 06/01/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/22/2026
• 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
• Patient Age: 75 YR
• Patient Sex: Unknown