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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); Urinary Frequency (2275); Discomfort (2330)
Event Date 03/15/2022
Event Type  Injury  
Event Description
It was reported that a patient underwent a water vapor therapy procedure.A few days post procedure the patient experienced some discomfort and noticed that the frequency to urinate had lessened.A few days after procedure, the patient went to the er and had the catheter removed as it was completely blocked.The patient noted that it was painful and began to feel the urge to frequently urinate.After a week, the patient had a follow-up with his physician for removal of the catheter.The patient stated that initially had feeling like was not completely emptying.
 
Manufacturer Narrative
Facility: (b)(4).Contact number: (b)(6).
 
Manufacturer Narrative
Facility: (b)(6).Physician: dr.(b)(6).Contact number: (b)(6).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 risk associated with a water vapor therapy procedure 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 and facility account number were 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, discomfort, urinary retention and urinary frequency 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.
 
Event Description
It was reported that a patient underwent a water vapor therapy procedure.A few days post procedure the patient experienced some discomfort and noticed that the frequency to urinate had lessened.A few days after procedure, the patient went to the er and had the catheter removed as it was completely blocked.The patient noted that it was painful and began to feel the urge to frequently urinate.After a week, the patient had a follow-up with his physician for removal of the catheter.The patient stated that initially had feeling like was not completely emptying.
 
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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 Key14174994
MDR Text Key289873950
Report Number2124215-2022-11958
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 Other
Type of Report Initial,Followup
Report Date 05/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/12/2022
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 Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient SexMale
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