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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
Model Number D2201
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Hematuria (2558); Erectile Dysfunction (4511)
Event Date 05/12/2021
Event Type  Injury  
Event Description
It was reported that the patient presented with an international prostate symptom score (ipps) of 28, an international index of erectile function (iief) score of 4 and a prostate volume of 53 cm3. The patient is a chinese male with medical history of gastrointestinal and neurological disorders. The patient was enrolled into the clinical study. During the water vapor therapy procedure of the prostate, there were a total of three treatments delivered to the right lobe, four treatments to the left lobe and one treatment to the middle lobe. Three days following the index procedure, the patient was reported to be experiencing hematuria. The patient was discharged from the medical facility on tamsulosin hydrochloride sustained-release capsule (dose unknown). At 34 days post the index procedure, the patient experienced erectile dysfunction and an urinary volume assessment test completed at 36 days post the index procedure, found the urinary volume at 142 ml with peak flow rate of 11 ml/sec. 152 days post the index procedure, the patient was diagnosed with prostatitis. The symptom of prostatitis was not considered to be resolved, and per the electronic data center (edc), there was no action taken to treat it. The investigator assessed the patient symptom of prostatitis as possible related to the procedure and device.
 
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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 Key12358242
MDR Text Key267815978
Report Number2124215-2021-25378
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number0026343797
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 Received08/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2020
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: 08/24/2021 Patient Sequence Number: 1
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