MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number D2201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Dysuria (2684)

Event Date 10/05/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a water vapor therapy procedure under anesthesia.The procedure was completed without patient complications.Then, 86 days after the procedure, the patient presented a prostate obstruction and dysuria caused by a prominent middle lobe protruding into the bladder, diagnosed through a flexible urinary fibroscopy.This patient was treated with dutasteride and tamsulosin medication, however the event is still on going.This event is possibly related to the water vapor therapy procedure.

Event Description

It was reported that the patient underwent a water vapor therapy procedure under anesthesia.The procedure was completed without patient complications.Then, 86 days after the procedure, the patient presented a prostate obstruction and dysuria caused by a prominent middle lobe protruding into the bladder, diagnosed through a flexible urinary fibroscopy.This patient was treated with dutasteride and tamsulosin medication, however the event is still on going.The treatment plan for the patient will include an exclusive enucleation of the middle lobe.This event is possibly related to the water vapor therapy procedure.

Manufacturer Narrative

The complaint component has not been returned; therefore, no physical or visual analysis of the product could be performed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.The data reasonably suggest that the clinical event of a prominent middle lobe protruding into the bladder causing dysuria not related to the device, possibly related to the procedure with dutasteride and tamsulosin medication treatment are anticipated in nature and severity as per instructions for use and hazard analysis.In addition, the reported patient symptoms of dysuria and obstruction are a known inherent risk of device use as documented in the product instructions for use.

• Brand Name: REZUM
• Type of Device: 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 5798
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19117750
• MDR Text Key: 340293838
• Report Number: 2124215-2024-22169
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2023
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0028136918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 68 KG