MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number D2201

Device Problems Pressure Problem (3012); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 04/14/2021

Event Type  malfunction  

Event Description

It was reported that during a water vapor therapy procedure, a total of three delivery devices were not able to complete priming.Error codes 240 and/or 235 were received with each delivery device.Troubleshooting was performed by turning off and on the generator; however, the issue was not resolved.The patient was present and sedated when the errors were received.The patient was woken up and the procedure was rescheduled.This report is for procedure rescheduled with patient under sedation.

Manufacturer Narrative

Additional information provided in: b5 describe event or problem.Investigation summary: with the available information boston scientific concluded that the reported inability to prime the delivery device and error codes cannot be confirmed.Visual analysis did not identify any internal or external physical damages that could have caused or contributed to the reported event.In addition, during functional testing, the delivery device was able to retract/deploy the needle, successfully performed prime, and delivered five treatments, as intended.Based on review of the information available, there was no problem detected with the delivery device.Device history record (dhr) review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the delivery device was returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.During visual analysis, the delivery device backplate was removed for inspection of the coil which appeared to be in good condition.During functional testing, the delivery device was connected to the lab generator.The retract/deploy needle functionality worked as intended.The delivery device successfully performed prime, pretreatment and five treatments without any issues.The pressure, temperature and radio frequency (rf) were monitored and no abnormalities were identified.No luer leaks were found, no kinks were observed in the tubing lines, and no errors messages were prompted on the generator screen.The delivery device functioned as intended.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of no problem detected was assigned to this investigation due to the device condition and successful functional testing.

Event Description

It was reported that during a water vapor therapy procedure, a total of three delivery devices were not able to complete priming.Error codes 240 and/or 235 were received with each delivery device.Troubleshooting was performed by turning off and on the generator; however, the issue was not resolved.The patient was present and sedated when the errors were received.The patient was woken up and the procedure was rescheduled.The physician later used another generator to test the delivery devices and they worked.He believes the priming errors were related to the generator.This report is for procedure rescheduled with patient under sedation.

• 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: 11721246
• MDR Text Key: 247250717
• Report Number: 2124215-2021-09717
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2022
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0026581613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1