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 Urinary Tract Infection (2120); Urinary Frequency (2275); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)

Event Date 11/22/2021

Event Type  Injury  

Event Description

Boston scientific became aware of a patient experience post rezum procedure. The patient opted for rezum because it was a less invasive procedure. The patient underwent the procedure on (b)(6) 2021. The patient reports that it is past 3 months post procedure recovery period and is still experiencing incontinence and frequency symptoms. The patient has been on a series of antibiotics for urinary trat infection (uti) post procedure. In addition, the patient is taking meloxicam and vibegron and solifenacin (unknown dose) medications. The patient continued to experience leakage as well as frequency symptoms. Since the procedure the flow is much improve but the incontinence requires wearing a pad and shield. The patient expressed understanding of not seeing full improvement for three months; but did not expect to experience issues after three months.

• 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: 13777927
• MDR Text Key: 287256567
• Report Number: 2124215-2022-07523
• 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,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• 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?: No
• Date Manufacturer Received: 03/16/2022
• 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 Treatment Data

Date Received: 03/16/2022 Patient Sequence Number: 1