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 Sepsis (2067); Urinary Tract Infection (2120); Patient Problem/Medical Problem (2688)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact date of the event was not reported.

Event Description

Boston scientific received information indicating that three patients who underwent a convective radiofrequency water vapor thermal therapy procedure developed an interprostatic urinoma post-procedure.It was reported that the patients physician attributed this to the steam hollowing out a cavity in the prostate, leaving the urethral prostatic tissue untouched.This allowed urine to gather in the cavity, causing a urinary tract infection (uti) and prolonged irritative symptoms (approximately 4-6 weeks).In one case, sepsis developed.Magnetic resonance imaging (mri) was used to identify the interprostatic urinoma filled with urine.In each case, a transurethral resection of the prostate (turp) was then performed to cut the prostatic urethral tissue, removing the cavity/urinoma and resolving the patients problem.Available information indicates that the patients are expected to make a full recovery.2 of 3.

• 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: alyson harris ; 150 baytech drive; san jose, CA 95134 ; 4089353452
• MDR Report Key: 10442909
• MDR Text Key: 204034378
• Report Number: 2937094-2020-00756
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• 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
• Date Manufacturer Received: 08/04/2020
• 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