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 Renal Failure (2041); Urinary Retention (2119)

Event Date 12/04/2020

Event Type  Injury  

Event Description

It was reported that patient had a convective radiofrequency water vapor thermal therapy, consisting on three treatments to the left lateral lobe and three treatments to the right lateral lobe of the prostate.After the procedure, a foley catheter was placed for six days and when removed, the patient went into urinary retention passing two voiding trials in the office, leading to an acute renal failure.The patient went to the emergency room and had the foley replaced for one week.He has had three episodes of retention since then.The patient is currently on clean intermittent catheterization (cic) and his renal function is almost normalized.

Event Description

It was reported that patient had a convective radiofrequency water vapor thermal therapy, consisting on three treatments to the left lateral lobe and three treatments to the right lateral lobe of the prostate.After the procedure, a foley catheter was placed for six days and when removed, the patient went into urinary retention passing two voiding trials in the office, leading to an acute renal failure.The patient went to the emergency room and had the foley replaced for one week.He has had three episodes of retention since then.The patient is currently on clean intermittent catheterization (cic) and his renal function is almost normalized.

Manufacturer Narrative

Investigation summary: with all the available information, boston scientific concludes that there was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risk associated with a water vapor therapy procedure and are noted as such in the device instructions for use.Device history review: a dhr and ship history review cannot be performed as the lot number and facility account number were not available.Device technical analysis: the product has not been returned; therefore, no physical or visual analysis of the product could be performed.Labeling review: the delivery device instructions for use (ifu) was reviewed.The patient symptoms of urinary retention and renal failure were found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherit 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
• MDR Report Key: 11310197
• MDR Text Key: 231318876
• Report Number: 2937094-2021-00109
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• 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
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR