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 Sepsis (2067); Urinary Tract Infection (2120)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date is unknown.

Event Description

It was reported that a patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate as planned.During procedure, there were no delivery device malfunctions.The procedure was successfully completed.The patient developed a urinary tract infection (uti) and went into sepsis post procedure.The patient was admitted to the hospital for standard care and the treatment administered is unknown.The patient was reported to have fully recovered.

Manufacturer Narrative

B3 date of event: exact date is unknown.Boston scientific has been unable to obtain additional information regarding the lot number and device availability, despite good faith efforts.Therefore device physical analysis and device history record (dhr) review cannot be performed.A device ship history review was performed for the reporting customer.This review did not identify delivery devices shipped to the customer in the past 3 years from awareness date of the reported event.The device instructions for use (ifu) list urinary tract infection and infection (sepsis) as risks associated with the use of the device and type of procedure; therefore, an evaluation conclusion code of known inherit risk of device was assigned to this investigation.

Event Description

It was reported that a patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate as planned.During procedure, there were no delivery device malfunctions.The procedure was successfully completed.The patient developed a urinary tract infection (uti) and went into sepsis post procedure.The patient was admitted to the hospital for standard care and the treatment administered is unknown.The patient was reported to have fully recovered.No further information is available.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 10489637
• MDR Text Key: 205887933
• Report Number: 3001236349-2020-00023
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K191505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• 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
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention