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 Pain (1994); Urinary Retention (2119); Hematuria (2558); Unspecified Kidney or Urinary Problem (4503)

Event Date 02/01/2022

Event Type  Injury  

Event Description

It was reported to boston scientific via an article published in journal of endourology that a prospective study was conducted to compare the sexual and urinary outcomes of water vapor intraprostatic injection in patients satisfying inclusion criteria of the randomized controlled trial (rct) with unselected patients.All patients with symptomatic benign prostatic hyperplasia (bph) who underwent water vapor therapy at eight institutions were followed and analyzed the functional results.Patients were divided in two groups: patients who matched the 5-year rct inclusion criteria (group a) and patients who did not (group b).The pre- and postoperative data, complications, presence of antegrade ejaculation, and urinary and sexual outcomes were periodically recorded.A total of 426 patients were eligible for the study (232 in group a and 194 in group b).Patients in group b had a higher american society of anesthesiologists score, prostate volume, and postvoid residual measurement.No difference was found in terms of preoperative international prostate symptom score, international index of erectile function, maximum urinary flow, and prostate-specific antigen.Longer operative time and higher number of vapor injections were required in group b, with no differences in hospital stay, injection density, and complication rates.All the urinary and sexual outcomes improved with no differences between the two groups.The reintervention rate at the latest follow-up visit was 2.6% in group a and 3.1% in group b.The overall complication rate between the groups was similar (31% vs 26.2%).Reported complications were clot retention, acute urinary retention (aur), hematuria, lower urinary tract symptoms (luts) and groin pain, resulting in blood transfusion, bladder irrigation and catheterization.Water vapor intraprostatic injections showed a safe and effective profile regardless of the prostate size, presence of indwelling catheter, antiplatelet/anticoagulant medications, and patients comorbidities.

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.Cindolo, l., campobasso, d., conti, e., uricchio, f., franzoso, f., maruzzi, d., viola, l., varvello, f., balsamo, r., ferrari, g., morselli, s., & siena, g.(2023).Do patients treated with water vapor therapy and meeting randomized clinical trial criteria have better urinary and sexual outcomes than an unselected cohort?.Journal of endourology, 37(3), 323-329.Https://doi.Org/10.1089/end.2022.0637.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18066179
• MDR Text Key: 327295366
• Report Number: 2124215-2023-61635
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2023

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: 10/13/2023
• Initial Date FDA Received: 11/03/2023
• 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; Other; Hospitalization
• Patient Sex: Male