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

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

Patient Problems Fatigue (1849); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Cognitive Changes (2551); Weight Changes (2607); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

Referred to treating physician by: dr. (b)(6). Treating physician: dr. (b)(6). Facility location is unknown.

Event Description

It was reported by the patient that on (b)(6) 2019, he consulted with his urologist the possibility of undergoing water vapor therapy with rezum. During the consultation, the patient s prostate was confirmed to measured 133g. The urologist indicated that water vapor therapy with rezum is approved by fda for up to 80g. Prostate gland. Prior to the procedure, preliminary cystoscopy noted obstruction, and also extension of the patient s prostate into the bladder which the urologist indicated it could be eliminated with the rezum procedure. The patient underwent the water vapor therapy with rezum on (b)(6) 2019. During the procedure under local anesthesia, the patient experienced pain, and was screaming. The patient was released after the procedure. While driving home, the patient began to experience bladder spasms. Apparently, the medical staff did not provide post operation medications to alleviate bladder spasms. Approximately two months following the index procedure, the patient began to urinate frequently and dribble urine. The patient followed-up with a different physician and prescribed oxybutynin and physical therapy. In addition, the physician suggested the patient to go back to his treating urologist. The patient soon began to experience painful urination and frequently urinating every 10-15minutes. The patient visited the (b)(6) emergency room; however, the er physician refused to see him and instead recommended to see his treating urologist. On (b)(6) 2021 the patient was able to visit his urologist for a cystoscopy. The patient was unable to explain all the symptoms experienced as the urologist interrupted him. During the cystoscopy, the urologist continued to state that there were no obstructions. However, per the urologist previous report, there were obstructions and extension of the patient s prostate was protruding into the bladder. The patient followed up with a physiotherapist for the frequent urination and a psychiatrist for the pain, as suggested by the treating urologist. The patient indicated that the biggest issue along with the pain, was not being able to sleep due to the frequent urination and pain. Due to the lack of sleep, the patient loss over 20lbs. And developed extreme brain fog, which made it impossible to work or perform basic daily life functions. The patient sought out another urologist around (b)(6) 2021. The urologist performed a holmium laser enucleation of the prostate (holep) procedure, and the patient reported that he has seen improvement after the holep treatment.

• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 12059234
• MDR Text Key: 258102664
• Report Number: 2124215-2021-17332
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/24/2021 Patient Sequence Number: 1