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 Impotence (1925); Pain (1994); Staphylococcus Aureus (2058); Depression (2361)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

The exact event date is unknown.

Event Description

The spouse of the patient contacted boston scientific to report that her husband was explained that one of the benefits of water vapor therapy was that it did not cause erectile dysfunction.However, the patient has experienced erectile dysfunction, staphylococcus aureus infection and constant life altering prostate paint during the 4 months post procedure.The spouse of the patient expressed that this has caused the patient stress, grief, depression and decreased in quality of life.The spouse mentioned that it is important to document these side effects of the water vapor therapy in order to consider other alternatives.No other patient complications were reported.

Manufacturer Narrative

B3: the exact event date is unknown.The device is not available for analysis; therefore, a physical as well as visual evaluation cannot be performed.The device history record (dhr) review cannot be completed as the lot number was not provided and the device was not returned for analysis resulting in an inability to identify the correct lot number.Review of the complaint information and the instructions for use, did not reveal any evidence of device off-label use or failure to follow instructions.The report of erectile dysfunction, pain and infection were identified in the instructions for use (ifu).Based on the information currently available an evaluation conclusion code of known inherent risk of device was assigned to this investigation.Depression is not listed as an anticipated symptom but likely a cascade of these events.Based on the information currently available an evaluation conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

The spouse of the patient contacted boston scientific to report that her husband was explained that one of the benefits of water vapor therapy was that it did not cause erectile dysfunction.However, the patient has experienced erectile dysfunction, staphylococcus aureus infection and constant life altering prostate paint during the 4 months post procedure.The spouse of the patient expressed that this has caused the patient stress, grief, depression and decreased in quality of life.The spouse mentioned that it is important to document these side effects of the water vapor therapy in order to consider other alternatives.No other patient complications were reported.

• 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: 10683020
• MDR Text Key: 211445914
• Report Number: 3001236349-2020-00025
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K191505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

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
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 11/14/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other