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

Model Number D2201

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

Event Description

It was reported that after connecting the delivery device to the generator for a water vapor therapy prostate treatment, error 235 code prompted on the generator screen.The water did not get hot enough to perform the initial water vapor treatment with the delivery device.A second delivery device was tried; however, 35002 error code prompted on the generator screen.The procedure was cancelled and the patient was under sedation when the error codes occurred.Although the patient was under sedation at the time, there were no complications to the patient as a result of the event.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Event Description

It was reported that after connecting the delivery device to the generator for a water vapor therapy prostate treatment, error 235 code prompted on the generator screen.The water did not get hot enough to perform the initial water vapor treatment with the delivery device.A second delivery device was tried; however, 35002 error code prompted on the generator screen.The procedure was cancelled and the patient was under sedation when the error codes occurred.Although the patient was under sedation at the time, there were no complications to the patient as a result of the event.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Manufacturer Narrative

Investigation summary: with the available information boston scientific concluded that the reported event was confirmed as analysis found error 235 was received.Error 235 requirement states that a non-critical error will be reported if a temperature value read from a delivery device thermocouple is below the normal operating range during vapor prime or pre-treatment vapor cycle.The outlet temperature is supposed to increase along with the coil temperature, but it decreased during functional testing.Based on review of all the information available and analysis result, the exact cause that contributed to the reported event and delivery device behavior during functional testing cannot be established.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.The backplate was removed from the handpiece so the coil could be visually inspected.Visual analysis found the coil was in good condition.The device was returned without the retraction button so a replacement retraction button was placed onto the device for functional testing.The feel and functionality of the delivery device button worked as intended.The delivery device was functionally tested using the lab generator.The original syringe that was returned with the delivery device was used during functional testing.During functional testing, error 235 (device displays 235 low temperature (prime)) was received.Error 235 requirement state: a non-critical error will be reported if a temperature value read from a delivery device thermocouple is below the normal operating range during vapor prime or pre-treatment vapor cycle.Error 235 specification state: if the coil temperature is below 105 c or the outlet temperature is below 90 c during vapor prime or pre-treatment vapor cycle, the generator shall report non-critical error 235 (prime) and disable the delivery device.The user shall be instructed to replace the delivery device.During functional testing, the delivery device was unplugged and plugged and error 235 was encountered again.The coil temperature was observed to be hovering around the low and mid 100s c (celsius) and the outlet temperature was in the mid 110s c.There were no leaks or kings in the lines and there were no anomalies observed with the syringe.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, the exact cause that contributed to the outlet temperature not to increase along with coil temperature which ultimately resulted in the error 235 cannot be established.Therefore, a conclusion code of cause not established 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: 12103806
• MDR Text Key: 259579298
• Report Number: 2124215-2021-18060
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2023
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0026955317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GENERATOR:MODEL G200.; GENERATOR:MODEL G200.