MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Device Problem Insufficient Information (3190)

Patient Problem Urinary Frequency (2275)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

Investigation summary: based on the information available, there was no device available for analysis and there was no device performance allegation during treatment.The reported patient symptoms of urinary frequency are a known risk associated with a water vapor therapy procedure and are noted as such in the device instructions for use.Device history record: the device history record (dhr) cannot be performed as the lot number and facility account number were not available.Labeling review: the delivery device instructions for use (ifu) was reviewed.The patient symptoms of urinary frequency were found to be listed in the ifu.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could not be performed.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported by a patient that following a water vapor therapy procedure he is urinating every two hours.He has consulted with his physician with no solution.

• 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: 12359149
• MDR Text Key: 267853536
• Report Number: 2124215-2021-25476
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• 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?: Yes
• Date Manufacturer Received: 07/29/2021
• 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): Other