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	Fistula (1862)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a water vapor therapy procedure to treat benign prostatic hyperplasia (bph).Fowwing the procedure, a recta fistula developed which was sealed with adhesive at the urinary tract side the procedure was completed with the original device.The patient is currently under observation.
Event or Problem Description
It was reported that a patient underwent a water vapor therapy procedure to treat benign prostatic hyperplasia.Following the procedure, a rectal fistula developed, which was sealed with adhesive from the urinary tract side.The patient is currently under observation.The procedure was completed with this device.The patient outcome information was not reported.
Additional Manufacturer Narrative
Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.

• 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: 50100616
• Report Number: 2124215-2026-41270
• Device Sequence Number: 10368659
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2026

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?: Yes
• 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: 07/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/24/2026
• 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; Other
• Patient Sex: Unknown