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 Urinary Retention (2119); Urinary Tract Infection (2120); Dysuria (2684); Unspecified Kidney or Urinary Problem (4503)

Event Date 04/01/2019

Event Type  Injury  

Event Description

It was reported to boston scientific via an article published in journal of sexual medicine that a prospective study was conducted to evaluate a prostatic block in a cohort of patients receiving a water vapor therapy procedure, in improving short term exacerbation of lower urinary tract dysfunction (luts).A total of 93 patients who underwent a water vapor therapy for benign prostatic hyperplasia (bph) in a single surgeon retrospective study was evaluated.All patients underwent a prostatic block, patient reported outcomes and complication rates were reviewed.Patients were selected to receive the therapy if prostate size was less than <110 grams, international prostate symptom score (ipps) score >15, and a desire for a minimally invasive luts treatment.Patients were given a post op course of antibiotics and instructed to take tylenol or non-steroidal anti-inflammatory drugs (nsaids) as needed.Post-procedure patients were sent home with a foley catheter for 48 hours.Patients were given a prostatic block consisting of 5 cc of 0.5% lidocaine and 5cc of 0.5% bupivicaine.The patients received transrectal ultrasound guided 2 cc injections, 2 cc by the bladder neck and sphincter, 2cc midline by the prostate and seminal vesicle junction, 2 cc by each prostatic capsule, and 2 cc by the prostatic midline septum.Mild exacerbation of luts or dysuria was reported in 9% (9/93) of patients.No patients reported luts exacerbation < 36 hours post procedure.No patients required post-op narcotics, pyridium or any anticholinergic.Two patients required replacement of foley catheter, one patient developed retention 1-week post-op and one patient developed a febrile urinary tract infection (uti).The prostatic block provided long-acting prostatic anesthesia, that reduced post-procedure discomfort.This was likely due to slow acclimation to the catheter placement while still having effective local anesthetic at the bladder neck and sphincter.

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.

• 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: 17127230
• MDR Text Key: 317206145
• Report Number: 2124215-2023-27296
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• 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: 05/22/2023
• Initial Date 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): Hospitalization; Required Intervention