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 Discomfort (2330); Obstruction/Occlusion (2422); Dysuria (2684)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Event date: the exact event date is unknown.

Event Description

It was reported that during a convective radiofrequency water vapor thermal therapy procedure, the tissue was treated too far from the bladder neck and the median lobe was left untreated.This resulted in a crater forming distal to the median lobe.As a result, three months after the initial treatment there was an obstruction in the median lobe causing turbulent flow and discomfort.The physician then performed a transurethral resection of the prostate procedure in order to treat the patient.The patient has fully recovered.

Event Description

It was reported that during a convective radiofrequency water vapor thermal therapy procedure, the tissue was treated too far from the bladder neck and the median lobe was left untreated.This resulted in a crater forming distal to the median lobe.As a result, three months after the initial treatment there was an obstruction in the median lobe causing turbulent flow and discomfort.The physician then performed a transurethral resection of the prostate procedure in order to treat the patient.The patient has fully recovered.

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 symptoms are known risks associated with convective radiofrequency water vapor thermal therapy procedures and are noted as such in the device instructions for use.Device history record (dhr): a dhr and ship history review cannot be performed as the lot number was not available.Device 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 of dysuria, discomfort and ureter/urethra obstruction were found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherit risk of device was assigned to this investigation.

• 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: 11596273
• MDR Text Key: 243701761
• Report Number: 2937094-2021-00283
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

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: 03/05/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention