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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 Insufficient Information (3190)
Patient Problems Scar Tissue (2060); Sepsis (2067); Urinary Retention (2119); Urinary Tract Infection (2120); Unspecified Kidney or Urinary Problem (4503); Urinary Incontinence (4572); Insufficient Information (4580)
Event Date 05/01/2022
Event Type  Injury  
Event Description
It was reported that the patient had a rezum procedure and sustained permanent injuries to the prostate and or bladder and or bladder neck.The patient was unable to control his ability to urinate.The patient had further surgeries to place a suprapubic tube to drain urine from his bladder.The patient also suffered from frequent, multiple and chronic urinary tract infections, including sepsis.No further information is known at this time.
 
Manufacturer Narrative
Date of event: unknown, used the first day of the aware month.
 
Event Description
It was reported that the patient had a rezum procedure and sustained permanent injuries to the prostate and or bladder and or bladder neck.The patient was unable to control his ability to urinate.The patient had further surgeries to place a suprapubic tube to drain urine from his bladder.The patient also suffered from frequent, multiple and chronic urinary tract infections, including sepsis.No further information is known at this time.
 
Manufacturer Narrative
B3 date of event: unknown, used the first day of the aware month.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 implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
 
Event Description
It was reported that the patient had a rezum procedure and sustained permanent injuries to the prostate and or bladder and or bladder neck.The patient was unable to control his ability to urinate.The patient had further surgeries to place a suprapubic tube to drain urine from his bladder.The patient also suffered from frequent, multiple and chronic urinary tract infections, including sepsis.No further information is known at this time.
 
Manufacturer Narrative
B3 date of event: unknown, used the first day of the aware month.
 
Event Description
It was reported that, following rezum therapy for benign prostatic hyperplasia, this patient experienced recurrent urinary tract infections and sediment in his urine.One infection progressed to sepsis.It was noted that these issues may have led to development of a retrourethral fistula.Upon examination, no fistula was found, but a large prostatic cavity was identified.A suprapubic catheter was inserted to allow the cavity to heal.Approximately four months later, cystoscopy was performed.The cavity had reduced in size and scarring was noted in the urethra.Inspection of the bladder neck did not find evidence of scar contracture.Inspection of the bladder found no stones, tumor or lesions.A transurethral resection of the prostate (turp) procedure was performed the following month.Following the turp procedure, hematuria was identified and the patient reported he was stlll incontinent.
 
Manufacturer Narrative
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 implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
 
Manufacturer Narrative
B3 date of event: unknown, used the first day of the aware month.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 implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
 
Event Description
It was reported that the patient had a rezum procedure and sustained permanent injuries to the prostate and or bladder and or bladder neck.The patient was unable to control his ability to urinate.The patient had further surgeries to place a suprapubic tube to drain urine from his bladder.The patient also suffered from frequent, multiple and chronic urinary tract infections, including sepsis.No further information is known at this time.Additional information reported that the patient alleges he was left incontinent following the rezum procedure on (b)(6) 2021.
 
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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
john stoffregen
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key14592000
MDR Text Key293261884
Report Number2124215-2022-19445
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 Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received04/06/2023
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) Hospitalization; Other; Required Intervention;
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