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 Problem Urinary Retention (2119)

Event Date 10/28/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a water vapor therapy procedure to treat a 40ml prostate gland.During the procedure, the physician used the delivery device to administer one injection to each lobe of the prostate; however, the injections were unsuccessful along with catheter ablation.Following the procedure, the patient experienced inability to void.The physician and patient agreed to undergo an enucleation.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

Manufacturer Narrative

Investigation summary: based on the information available, there was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptom of urinary retention is a known risk associated with rezum water vapor therapy procedure and is noted as such in the device instructions for use (ifu).Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The patient symptoms of urinary retention is found to be listed in the ifu.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could not be performed.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.The patient symptom of urinary retention is noted in the device instructions for use; therefore, it is anticipated in nature.

Event Description

It was reported that the patient underwent a water vapor therapy procedure to treat a 40ml prostate gland.During the procedure, the physician used the delivery device to administer one injection to each lobe of the prostate; however, the injections were unsuccessful along with catheter ablation.Three days after the procedure, the patient experienced inability to void after the physician attempted to remove the catheter.The physician and patient agreed to undergo an enucleation.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• 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 ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 13358022
• MDR Text Key: 284452019
• Report Number: 2124215-2022-01320
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• 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): Other; Required Intervention