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 Abscess (1690); Endocarditis (1834); Fever (1858); Necrosis (1971); Sepsis (2067); Urinary Tract Infection (2120)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event date is unknown.

Event Description

It was reported that the patient underwent a water vapor therapy procedure in mid (b)(6) 2021.A total of seven treatments were administrated.Three treatments were delivered to the prostate left lobe, three to the right lobe and one to the middle lobe.The symptoms post procedure were normal, and the patient had a strong flow of urine.However, the patient experienced an urinary tract infection (uti) and fever.The patient presented to primary care physician and then followed up with his urologist for antibiotics and medications.After several weeks, the patient returned with fever to the emergency room.A computed axial tomography (cat) scan was performed and showed what was believed to be an abscess in the prostate.Upon attempted drainage, no infection or fluid was removed, but necrotic tissue was observed.The patient experienced prolonged bacteremia/urosepsis which resulted in endocarditis.The patient is currently awaiting an aortic valve repair due to the endocarditis from prolonged bacteremia.

Event Description

It was reported that the patient underwent a water vapor therapy procedure in (b)(6) 2021.A total of seven treatments were administrated.Three treatments were delivered to the prostate left lobe, three to the right lobe and one to the middle lobe.The symptoms post procedure were normal, and the patient had a strong flow of urine.However, the patient experienced an urinary tract infection (uti) and fever.The patient presented to primary care physician and then followed up with his urologist for antibiotics and medications.After several weeks, the patient returned with fever to the emergency room.A computed axial tomography (cat) scan was performed and showed what was believed to be an abscess in the prostate.Upon attempted drainage, no infection or fluid was removed, but necrotic tissue was observed.The patient experienced prolonged bacteremia/urosepsis which resulted in endocarditis.The patient is currently awaiting an aortic valve repair due to the endocarditis from prolonged bacteremia.

Manufacturer Narrative

B3 date of event: the exact event date is unknown.Investigation summary: based on the information available, there was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risks associated with water vapor therapy procedures and are noted as such in the device instructions for use.Device history record (dhr): a dhr and ship history review cannot be performed as the lot number was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Labeling review: the device instructions for use (ifu) and hazard analysis were reviewed.The patient symptoms of urinary infection, fever, abscess, necrosis and sepsis were found to be listed in the risk documentation.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

• 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: 12691101
• MDR Text Key: 278201106
• Report Number: 2124215-2021-32179
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Male