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 Micturition Urgency (1871); Urinary Retention (2119); Insufficient Information (4580)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

Dreyfuss ld, alter k, balasubramanian a, zisholtz b, zorn kc, bhojani n, elterman d, chughtai b.Peri-urethral prostatic cavity formation following water vapor thermal therapy: an unrecognized complication causing persistent luts? [abstract].J urol.2023: 209 (suppl 4): e1092.117th annual meeting of the american urological association, aua 2023 united states, chicago, il 2023-04-28 to 2023-05-01.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.This report is for the same event as manufacturer reports 2124215-2023-44267 and 2124215-2023-44274.

Event Description

It was reported to boston scientific via an article published in the journal of urology that the procedural outcomes of three patients who underwent water vapor thermal therapy (wvtt) procedures to treat lower urinary tract symptoms (luts) were reported.All patients had bothersome luts and a prostate volume less than 80 cc's.The wvtt procedures were performed under local anesthesia with 1-3 treatments in the bilateral lateral lobes.All three patients successfully underwent the wvtt procedure.Following the procedure, patient 1 experienced persistent bothersome luts.Urodynamics showed the patient had high pressure with low urinary flow.A cystoscopy was performed and revealed the urethral cavities were filled with debris causing an obstruction.A transurethral unroofing procedure was performed which resulted in a resolution of the patient's symptoms.Following the procedure, patient 2 experienced persistent luts, a slow urinary stream, and elevated post-void residual volumes.After five months of persistent symptoms, the patient began to experience watery ejaculate.A ct urogram revealed cystic dilation of the prostatic urethra with urethral stones.The patient underwent a cystoscopy and stone removal.Following the procedure, patient 3 experienced luts for two and a half months.Then the patient developed watery ejaculate.A cystoscopy was performed which revealed a prostatic urethral diverticulum.An mri showed a cystic cavity in the prostatic transition zone contiguous with the prostatic urethra.14 months after the wvtt procedure, the patient underwent a photoselective vaporization of the prostate procedure, and the symptoms resolved.At the final follow-up, all three patients were voiding well and had resolution of their luts.This report is for patient 2.

• 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: 17568834
• MDR Text Key: 321403291
• Report Number: 2124215-2023-44269
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2023

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: 07/28/2023
• Initial Date FDA Received: 08/17/2023
• 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