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 Problem Erectile Dysfunction (4511)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: actual event date is unknown.

Event Description

It was reported that the patient experienced erectile dysfunction issues after the treatment of the apical lobes of the prostate.It was noted that the delivery device performed as intended during use.

Manufacturer Narrative

B3.Date of event: actual event date is unknown.Investigation summary: based on the information available boston scientific (bsc) concluded, there was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptom is a known risk associated with a water vapor therapy procedure and is noted as such in the device instructions for use.Dhr review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Technical analysis: the device is not available for analysis; 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 erectile dysfunction was found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

It was reported that the patient experienced erectile dysfunction issues after the treatment of the apical lobes of the prostate.It was noted that the delivery device performed as intended during use.

• 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: 12481471
• MDR Text Key: 271695993
• Report Number: 2124215-2021-27871
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• 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: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other