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

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

Patient Problems Fever (1858); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); Hematuria (2558); Dysuria (2684); Fluid Discharge (2686); Urinary Incontinence (4572)

Event Date 11/21/2016

Event Type  Injury  

Event Description

It was reported to boston scientific via an article published in research and reports in urology that a prospective study was conducted in order to assess the two-year efficacy and safety of convective radiofrequency water vapor therapy procedures in men with lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia (bph).A total of 65 patients were involved in the study and underwent the procedure at one of three sites located in the dominican republic, czech republic, and sweden.Men involved in the study were 45 years or older, had no prior minimally invasive or surgical interventions for bph, prostate volume was 20cc - 120cc, international prostate symptom score (ipss) was greater than or equal to 13, the peak urinary flow rate (qmax) was less than or equal to 15 ml/s with a voided volume was greater than or equal to 125ml, and a post-void residua volume (pvr) was less than 300ml.At the time of the procedure, 32.3% of patients had moderate luts, 67.7% had severe luts, and 48% of the patients had a history of concurrent erectile dysfunction (ed).All procedures were successfully completed without any perioperative serious device or procedure related adverse events.Of the 65 patients, 51 patients received only oral sedation and 14 patients received intravenous sedation for the procedure.Patient were assessed 1 week, 1 month, 3 months, 6 months, 12 months and 24 months post-procedure.Following the procedure, 36 patients were catheterized prior to discharge for the following reasons: 15 for precautionary measures, 14 for inadequate voiding, six for hematuria, and one for dysuria.Additionally, 11 patients were catheterized post-discharge for either urinary retention or travel convenience.One patient had persistent luts observed by poor stream, frequency, and urinary retention.The symptoms were reported as three separate serious adverse events related to the procedure.The median lobe had not been treated in this patient.This patient subsequently underwent a transurethral resection of the prostate (turp) procedure.The following number of patients with non-serious related adverse events were reported: 24 urinary retention, 14 dysuria, 14 urinary urgency, 13 suspected urinary tract infections (uti), 10 hematuria, 10 poor stream, 7 pain/discomfort, 6 nocturia, 5 urinary frequency, 3 urethral secretion without hematuria or stones, 3 fever, 2 terminal dribbling, 2 scrotal pain/discomfort, 2 urinary incontinence/urge, and an unspecified number of patients with hematospermia.Patients with uti were treated with antibiotics.In addition to the patient previously mentioned who underwent tupr, one patient underwent an open prostatectomy, and 5 patients underwent a second water vapor therapy procedure.Four patients were administered bph medications in the one to four month period following the procedure in order to treat intermittent residual luts.One patient started taking phosphodiesteras type 5 inhibitor one year after treatment.Overall, the water vapor therapy procedure showed clinically and statistically significant improvements in ipss, quality of life (qol), benign prostatic hyperplasia impact index (bphii), and qmax throughout the course of the two-year study.

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 implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.Correction provided in h10: added citation for article and added article to submission.Dixon c, cedano er, pacik d, et al.Two-year results after convective radiofrequency water vapour thermal therapy of symptomatic benign prostatic hyperplasia.Res rep urol 2016; 8: 207-216.

Event Description

It was reported to boston scientific via an article published in research and reports in urology that a prospective study was conducted in order to assess the two-year efficacy and safety of convective radiofrequency water vapor therapy procedures in men with lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia (bph).A total of 65 patients were involved in the study and underwent the procedure at one of three sites located in the dominican republic, czech republic, and sweden.Men involved in the study were 45 years or older, had no prior minimally invasive or surgical interventions for bph, prostate volume was 20cc - 120cc, international prostate symptom score (ipss) was greater than or equal to 13, the peak urinary flow rate (qmax) was less than or equal to 15 ml/s with a voided volume was greater than or equal to 125ml, and a post-void residua volume (pvr) was less than 300ml.At the time of the procedure, 32.3% of patients had moderate luts, 67.7% had severe luts, and 48% of the patients had a history of concurrent erectile dysfunction (ed).All procedures were successfully completed without any perioperative serious device or procedure related adverse events.Of the 65 patients, 51 patients received only oral sedation and 14 patients received intravenous sedation for the procedure.Patient were assessed 1 week, 1 month, 3 months, 6 months, 12 months and 24 months post-procedure.Following the procedure, 36 patients were catheterized prior to discharge for the following reasons: 15 for precautionary measures, 14 for inadequate voiding, six for hematuria, and one for dysuria.Additionally, 11 patients were catheterized post-discharge for either urinary retention or travel convenience.One patient had persistent luts observed by poor stream, frequency, and urinary retention.The symptoms were reported as three separate serious adverse events related to the procedure.The median lobe had not been treated in this patient.This patient subsequently underwent a transurethral resection of the prostate (turp) procedure.The following number of patients with non-serious related adverse events were reported: 24 urinary retention, 14 dysuria, 14 urinary urgency, 13 suspected urinary tract infections (uti), 10 hematuria, 10 poor stream, 7 pain/discomfort, 6 nocturia, 5 urinary frequency, 3 urethral secretion without hematuria or stones, 3 fever, 2 terminal dribbling, 2 scrotal pain/discomfort, 2 urinary incontinence/urge, and an unspecified number of patients with hematospermia.Patients with uti were treated with antibiotics.In addition to the patient previously mentioned who underwent tupr, one patient underwent an open prostatectomy, and 5 patients underwent a second water vapor therapy procedure.Four patients were administered bph medications in the one to four month period following the procedure in order to treat intermittent residual luts.One patient started taking phosphodiesteras type 5 inhibitor one year after treatment.Overall, the water vapor therapy procedure showed clinically and statistically significant improvements in ipss, quality of life (qol), benign prostatic hyperplasia impact index (bphii), and qmax throughout the course of the two-year study.

• 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 Key: 16953486
• MDR Text Key: 315471013
• Report Number: 2124215-2023-24865
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 06/14/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/14/2023
• 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; Hospitalization