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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
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.
 
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Brand NameREZUM
Type of DeviceUNIT, 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 Key13361284
MDR Text Key284519565
Report Number2124215-2022-01591
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/26/2022
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 Received02/04/2022
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
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