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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); Urinary Retention (2119); Discomfort (2330); Hematuria (2558); Swelling/ Edema (4577)
Event Date 12/16/2021
Event Type  Injury  
Event Description
It was reported that two hours post a water vapor therapy surgery, a patient returned to the clinic experiencing pain and swelling. The swelling had closed the prostate and led to urinary retention. The physician placed another catheter for an additional seven days. When the patient returned to the clinic seven days post the placement of the catheter, the physician noted that the bladder of the patient was filled with 310 cubic centimeters (cc) of urine. The physician told the patient to return home and prescribed inflammatory medication. The same night, the patient went to the hospital emergency room to have another catheter placed. The patient was administered more medications and was told to return within two weeks. Two weeks post the hospital emergency room visit, the patient returned and was told he had 210 cubic centimeters (cc) of urine in the bladder. The patient went back home and tried an intermittent catheter which would not go all the way in. As a result, the patient had another catheter put in for another two weeks. Ever since the water vapor therapy procedure, the patient is experiencing daily uncomfortable symptoms such as pinching, hurting, being uncomfortable, bleeding. The patient was scheduled to return to see the physician on (b)(6) 2022. Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
 
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 are known risks associated with water vapor therapy procedures and are 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 symptoms of pain, inflammation (swelling), urinary retention, discomfort and hematuria were 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.
 
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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 Key13446152
MDR Text Key285036734
Report Number2124215-2022-02206
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received01/18/2022
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: 02/03/2022 Patient Sequence Number: 1
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