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 Complaint, Ill-Defined (2331); Hematuria (2558); Patient Problem/Medical Problem (2688)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that patient had convective radiofrequency water vapor thermal therapy procedure done a year ago.Patient states he experienced urinating blood two and a half to three months after procedure took place.He noticed that the effects of the procedure lasted seven months.

Manufacturer Narrative

H6.Patient code 2688 is being used for the ineffective treatment the device is not available for analysis.A review of the ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.Based on review of the information available, hematuria and patient problem/medical problem are known risks associated with the use of the device and are noted as such in the instructions for use (ifu).An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

It was reported that patient had convective radiofrequency water vapor thermal therapy procedure done a year ago.Patient states he experienced urinating blood two and a half to three months after procedure took place.He noticed that the effects of the procedure lasted seven months.

• 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: 10742371
• MDR Text Key: 213406980
• Report Number: 2937094-2020-00904
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other