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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 Sepsis (2067); Urinary Tract Infection (2120)
Event Date 01/01/2021
Event Type  Injury  
Event Description
It was reported that following a successful water vapor therapy procedure, the physician found an intraprostatic urinoma which led to an urinary tract infection (uti).The infection then progressed to sepsis.The physician believes the intraprostatic urinoma was created by leaving tissue adjacent to the prostatic urethra untouched while removing other tissue.The cavity in the prostate eventually filled with urine and became infected.The physician performed a transurethral resection of the prostate (turp) to remove the intraprostatic urinoma, and the patient was reported to have made full recovery.
 
Event Description
It was reported that following a successful water vapor therapy procedure, the physician found an intraprostatic urinoma which led to an urinary tract infection (uti).The infection then progressed to sepsis.The physician believes the intraprostatic urinoma was created by leaving tissue adjacent to the prostatic urethra untouched while removing other tissue.The cavity in the prostate eventually filled with urine and became infected.The physician performed a transurethral resection of the prostate (turp) to remove the intraprostatic urinoma, and the patient was reported to have made full recovery.
 
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 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 urinary tract infection (uti) and sepsis 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 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
MDR Report Key11596014
MDR Text Key243749081
Report Number2937094-2021-00281
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K180237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberD2201
Device Catalogue NumberD2201
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/04/2021
Initial Date FDA Received03/31/2021
Supplement Dates Manufacturer Received04/08/2021
Supplement Dates FDA Received04/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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