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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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BOSTON SCIENTIFIC CORPORATION REZUM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number G2200
Device Problem Insufficient Information (3190)
Patient Problem Urinary Retention (2119)
Event Date 02/16/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is unknown.Healthcare facility: (b)(6).Physician: dr.(b)(6).
 
Event Description
Boston scientific became aware of a patient that is still using catheters four weeks post his rezum water vapor therapy procedure.The patient suggested that the rezum device might be the issue.However, boston scientific has been unable to obtain additional information regarding possible issues with the device during treatment to date, despite good faith efforts.
 
Manufacturer Narrative
Date of event is unknown.Healthcare facility: (b)(6).Physician: dr.(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 symptom of urinary retention is a known risk associated with rezum procedures and is noted as such in the device instructions for use.Device history record (dhr): the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.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 symptom urinary retention 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
Boston scientific became aware of a patient that is still using catheters four weeks post his rezum water vapor therapy procedure.The patient suggested that the rezum device might be the issue.However, boston scientific has been unable to obtain additional information regarding possible issues with the device during treatment to date, despite good faith efforts.
 
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Brand Name
REZUM
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11449101
MDR Text Key238878210
Report Number2937094-2021-00230
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
PMA/PMN Number
K180237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 04/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberG2200
Device Catalogue NumberG2200
Was Device Available for Evaluation? No
Date Manufacturer Received03/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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