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 Hemorrhage/Bleeding (1888); Urinary Retention (2119)

Event Date 06/30/2022

Event Type  Injury  

Event Description

It was reported that a patient with an urinary retention medical history, underwent a water vapor thermal therapy procedure.Six days after the procedure, the patient had an appointment in which a catheter was removed and a new one was placed.Upon removal, some blood was seen in the head of the penis and the urethral entrance.Following this appointment, the patient still experienced bleeding and pressure when sitting down.The physician scheduled a nurse to replace the catheter in a home visit; however, the patient cancelled the appointment and contacted the physician again.The patient believed the procedure did not work because he could not urinate by himself.

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 was unable to be performed as the lot number is unknown.Due to the lack of product return, the clinical observations of urinary retention, and bleeding could not be confirmed.However, the reported patient symptoms are known risks associated with the use of this device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that a patient with an urinary retention medical history, underwent a water vapor thermal therapy procedure.Six days after the procedure, the patient had an appointment in which a catheter was removed and a new one was placed.Upon removal, some blood was seen in the head of the penis and the urethral entrance.Following this appointment, the patient still experienced bleeding and pressure when sitting down.The physician scheduled a nurse to replace the catheter in a home visit; however, the patient cancelled the appointment and contacted the physician again.The patient believed the procedure did not work because he could not urinate by himself.

• 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
• MDR Report Key: 15080277
• MDR Text Key: 296369199
• Report Number: 2124215-2022-26887
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/26/2022
• 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): Other
• Patient Age: 83 YR
• Patient Sex: Male