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 Unspecified Infection (1930)

Event Date 03/24/2020

Event Type  Injury  

Event Description

It was reported the patient had a 50cc prostate gland.The patient underwent successful convective radiofrequency water vapor thermal therapy procedure.During the procedure, a total of two treatment were delivered to each lob.There was an elevated central zone that was not treated.The catheter placed post procedure was successfully removed 13 days post the index procedure.It was reported that 21 days post procedure, the patient went to the emergency room and was admitted for three days and treated for epididymitis, which the surgeon attributed to the convective radiofrequency water vapor thermal therapy treatment.The infection was successfully treated, and per the surgeon, the convective radiofrequency water vapor thermal therapy treatment was successful because the post void residual (pvr) was reduced by 500cc and the post procedure international prostate symptom score (ipss) was 3.No further information was provided.

Manufacturer Narrative

The device lot number was not reported despite due diligence; therefore, a device history record could not be performed.A shipping history was revealed 25049907 and 24920254 as potential lots present at the customer facility.A review of the device history record of the two lot numbers confirmed that the devices met all material, assembly and performance specifications.The subject device is not available for analysis; therefore, analysis could not be performed.Labeling review did not find evidence of device off-label use or failure to follow instructions.Based on the information currently available an evaluation conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported the patient had a 50cc prostate gland.The patient underwent successful convective radiofrequency water vapor thermal therapy procedure.During the procedure, a total of two treatment were delivered to each lob.There was an elevated central zone that was not treated.The catheter placed post procedure was successfully removed 13 days post the index procedure.It was reported that 21 days post procedure, the patient went to the emergency room and was admitted for three days and treated for epididymitis, which the surgeon attributed to the convective radiofrequency water vapor thermal therapy treatment.The infection was successfully treated, and per the surgeon, the convective radiofrequency water vapor thermal therapy treatment was successful because the post void residual (pvr) was reduced by 500cc and the post procedure international prostate symptom score (ipss) was 3.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 10280655
• MDR Text Key: 199070931
• Report Number: 3001236349-2020-00017
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 63 YR