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); Laceration(s) (1946)

Event Date 08/10/2021

Event Type  Injury  

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 is a known risks associated with water vapor therapy procedures and is 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: the delivery device instructions for use (ifu) was reviewed. The patient symptom of hematuria was found to be listed in the ifu. Investigation conclusion: based on the information available, a conclusion code of known inherit risk of device was assigned to this investigation.

Event Description

It was reported that during a water vapor therapy procedure, the physician pushed too hard past the right sulcus navigating over the median lobe tearing the mucosa. However, false passage did not occur in the mucosa due to the reported delivery device manipulation. After completing the water vapor therapy procedure, the physician felt it was necessary to use a bipolar transurethral resection of the prostate (turp) to cauterize the bleeding vessel. The bleeding stopped and the patient was sent to recovery. The patient is expected to fully recover and was not admitted beyond the standard of care.

• 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: 12388737
• MDR Text Key: 268874599
• Report Number: 2124215-2021-25804
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• 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?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/10/2021
• 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 Treatment Data

Date Received: 08/30/2021 Patient Sequence Number: 1