MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	G2200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Micturition Urgency (1871)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the water vapor therapy procedure was performed without device issues or patient complications.Four steam injections were performed on the right lobe and four on the left lobe, with minor bleeding in each case.No injections were performed in the middle lobe.However, almost a year after treatment the patient experienced mild urinary urgency, hence, medication was administered.The medication used was an androgenic receptor blocker.It was stated that the event is not related to the device but possibly to the procedure.
Additional Manufacturer Narrative
The device was not returned for product analysis.Therefore, the reported allegation could not be confirmed.Review of the instructions for use (ifu) confirmed that the reported symptom of urinary urgency is well-known and documented in the product labeling.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Correction to d10: concomitant product.
Event or Problem Description
It was reported that the water vapor therapy procedure was performed without device issues or patient complications.Four steam injections were performed on the right lobe and four on the left lobe, with minor bleeding in each case.No injections were performed in the middle lobe.However, almost a year after treatment the patient experienced mild urinary urgency, hence, medication was administered.The medication used was an androgenic receptor blocker.It was stated that the event is not related to the device but possibly to the procedure.

• Brand Name: REZUM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): NORTECH SYSTEM INC; nw 7791; 1450; minneapolis MN 55485 7791
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19756903
• Report Number: 2124215-2024-43793
• Device Sequence Number: 12980473
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K180237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: G2200
• Device Catalogue Number: G2200
• Device Lot Number: 0000004909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/26/2024
• Date Device Manufactured: 07/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: UPN: M006D2201-0032, BATCH: 0031315159
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 68 KG