MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number D2201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Bacterial Infection (1735); Fever (1858); Micturition Urgency (1871); Necrosis (1971); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Dysuria (2684); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/16/2023

Event Type  Injury  

Event Description

It was reported to boston scientific via an article published by the world journal of clinical cases, of a 63-year-old male case that had presented to an outpatient clinic 2 months prior for an acute urinary retention with preoperative prostate volume of 54 ml, and a prostatic urethral angulation.The patient underwent rezum therapy with water vaporization.The patient did not experience any intraoperative or immediate postoperative events.He was kept on suprapubic catheter after the procedure for 14 days.The patient experienced successful voiding with no residual urine on day 15 after the procedure.Ultrasound performed showed multiple hypoechoic gas areas within a retained soft tissue in the urinary bladder.Computed tomography of the kidney, ureter, and bladder was performed.It confirmed the presence of retained soft tissue within the urinary bladder with multiple air pockets.The urinary bladder wall was intact.The patient was diagnosed with complicated urinary tract infection and acute bacterial cystitis.The patient received intravenous ertapenem (1 g) daily in the peripheral primary health care center outside country as an outpatient till he was admitted to the treating center.A urethral catheter was inserted.Cystoscopy and necrotic tissue evacuation were performed under general anesthesia 3 days after presentation.Cystoscopy revealed a wide prostatic urethra without obstruction.The retained necrotic tissue was submitted for culture and revealed klebsiella colonization.The patient completed 2 weeks of intravenous antimicrobial therapy, and his symptoms resolved.At the 1-mo follow-up (3 mo after rezum therapy), the patient reported retrograde ejaculation.However, he voided successfully without luts.His international prostate symptom score was 2, indicating mild symptoms.The prostate size decreased from 54 ml to 7 ml.Pre-void urine volume was 335 ml, and post-void residual urine was 0 ml.In case study concluded that rezum therapy is a safe and effective new technology for the management of bph.The occurrence of complications is rare after rezum therapy.However, unexpected and unusual adverse events could occur similar to the retained emphysematous floating necrotic tissue as indicated in this case.

Manufacturer Narrative

Alnazari m, bakhsh a, rajih es.Emphysematous sloughed floating ball after prostate water vaporization rezum: a case report.World j clin cases 2023; 11(23): 5525-5529.

Event Description

It was reported to boston scientific via an article published in the world journal of clinical cases that a 63-year-old male with benign prostatic hyperplasia (bph) underwent rezum therapy.Two months prior to treatment, the patient had presented to an outpatient clinic for acute urinary retention with preoperative prostate volume of 54 ml, and a prostatic urethral angulation.The patient did not experience any intraoperative or immediate postoperative events.There were no device malfunctions or issues during the procedure.He was kept on suprapubic catheter for 14 days following the procedure.On day 15 post-procedure, the patient experienced successful voiding with no residual urine.At the one-month follow up, the patient reported retrograde ejaculation but voided successfully.Two months following the procedure, the patient presented to the clinic with severe dysuria, urinary frequency and urgency, fever, and interrupted urine stream.An ultrasound was performed that identified multiple hypoechoic gas areas within retained soft tissue in the urinary bladder.Computed tomography of the kidney, ureter, and bladder was performed which confirmed the presence of retained soft tissue with multiple air pockets within the urinary bladder.The urinary bladder wall was intact.The patient was diagnosed with complicated urinary tract infection and acute bacterial cystitis.The patient received intravenous ertapenem (1 g) daily in the peripheral primary health care center outside country as an outpatient until he was admitted to the treating center.A urethral catheter was inserted.Cystoscopy and necrotic tissue evacuation were performed under general anesthesia three days after presentation.Cystoscopy revealed a wide prostatic urethra without obstruction.The retained necrotic tissue was submitted for culture and revealed klebsiella colonization.The patient completed two weeks of intravenous antimicrobial therapy, and his symptoms resolved.At the one-month follow-up (three months after rezum therapy), the patient reported retrograde ejaculation.However, he voided successfully without lower urinary tract symptoms.His international prostate symptom score was 2, indicating mild symptoms and his prostate size had decreased from 54 ml to 7 ml.Pre-void urine volume was 335 ml, and post-void residual urine was 0 ml.This case study concluded that rezum therapy is a safe and effective technology for the management of bph.The occurrence of complications is rare after rezum therapy.However, unexpected and unusual adverse events could occur (e.G., the retained emphysematous floating necrotic tissue as indicated in this case).

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with this device and indicated as such in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.Alnazari m, bakhsh a, rajih es.Emphysematous sloughed floating ball after prostate water vaporization rezum a case report.World j clin cases 2023; (b)(6).

Event Description

It was reported to boston scientific via an article published in the world journal of clinical cases that a 63-year-old male with benign prostatic hyperplasia (bph) underwent rezum therapy.Two months prior to treatment, the patient had presented to an outpatient clinic for acute urinary retention with preoperative prostate volume of 54 ml, and a prostatic urethral angulation.The patient did not experience any intraoperative or immediate postoperative events.He was kept on suprapubic catheter for 14 days following the procedure.On day 15 post-procedure, the patient experienced successful voiding with no residual urine.At the one-month follow up, the patient reported retrograde ejaculation but voided successfully.Two months following the procedure, the patient presented to the clinic with severe dysuria, urinary frequency and urgency, fever, and interrupted urine stream.An ultrasound was performed that identified multiple hypoechoic gas areas within retained soft tissue in the urinary bladder.Computed tomography of the kidney, ureter, and bladder was performed which confirmed the presence of retained soft tissue with multiple air pockets within the urinary bladder.The urinary bladder wall was intact.The patient was diagnosed with complicated urinary tract infection and acute bacterial cystitis.The patient received intravenous ertapenem (1 g) daily in the peripheral primary health care center outside country as an outpatient until he was admitted to the treating center.A urethral catheter was inserted.Cystoscopy and necrotic tissue evacuation were performed under general anesthesia three days after presentation.Cystoscopy revealed a wide prostatic urethra without obstruction.The retained necrotic tissue was submitted for culture and revealed klebsiella colonization.The patient completed two weeks of intravenous antimicrobial therapy, and his symptoms resolved.At the one-month follow-up (three months after rezum therapy), the patient reported retrograde ejaculation.However, he voided successfully without lower urinary tract symptoms.His international prostate symptom score was 2, indicating mild symptoms and his prostate size had decreased from 54 ml to 7 ml.Pre-void urine volume was 335 ml, and post-void residual urine was 0 ml.This case study concluded that rezum therapy is a safe and effective technology for the management of bph.The occurrence of complications is rare after rezum therapy.However, unexpected and unusual adverse events could occur (e.G., the retained emphysematous floating necrotic tissue as indicated in this case).

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with this device and indicated as such in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.Alnazari m, bakhsh a, rajih es.Emphysematous sloughed floating ball after prostate water vaporization rezum: a case report.World j clin cases 2023; 11(23): (b)(6).

• 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): NORTECH SYSTEMS, INC.; 925 6th avenue ne; milaca MN 56353
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17999877
• MDR Text Key: 326450342
• Report Number: 2124215-2023-58464
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2023

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 Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: Not provided; 11/14/2023
• Supplement Dates FDA Received: 11/22/2023; 12/13/2023
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male