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 Problems Pain (1994); Scar Tissue (2060)

Event Date 12/01/2022

Event Type  Injury  

Event Description

It was reported by a customer that her husbands water vapor therapy procedure was dreadful as it was very painful.The procedure did not help the patient and caused him to develop peyronies disease.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

Manufacturer Narrative

Date of event: the exact event date is unknown.

Manufacturer Narrative

B3 date of event: the exact event date is unknown.Correction.G1 mfr site facility name: correction.There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms of pain and scar tissue (cicatrix) are known risks associated with use of these devices as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported by a customer that her husband's water vapor therapy procedure was dreadful as it was very painful.The procedure did not help the patient and caused him to develop peyronie's disease.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
• MDR Report Key: 15992412
• MDR Text Key: 305581169
• Report Number: 2124215-2022-52748
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other