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 Pain (1994); Obstruction/Occlusion (2422); Hematuria (2558)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Physician: dr. (b)(6). Date of event: (b)(6) 2021 is best estimate as the social media post is dated (b)(6) 2021.

Event Description

Boston scientific received information of a patient experience with rezum water vapor therapy treatment. The procedure was performed by dr. (b)(6) in a facility in the central (b)(6) region. Post procedure, the patient experienced complications due to tissue blocking the urethra. In addition, the patient was urinating blood for several days, and was experiencing pain. The patient ended up being admitted for three days in the hospital and was borderline transfusion. The patient underwent surgery to treat symptoms. Dr. (b)(6) who had originally performed the rezum treatment did not perform the surgery. There were no other patient adverse events reported.

• 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: 13361284
• MDR Text Key: 284519565
• Report Number: 2124215-2022-01591
• 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: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• 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: 02/04/2022
• 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: 01/26/2022 Patient Sequence Number: 1