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.

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 november 22, 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.

Manufacturer Narrative

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 risk 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.Labeling review a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Infection, urinary frequency, incontinence, urinary were found to be listed in the ifu.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: 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: Other
• 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: Health Professional
• 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 Sequence Number: 1
• Patient Outcome(s): Other