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

Model Number D2201

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

It was reported that while the staff started to do the injection with the delivery device, when an error message (wait for delivery device to cool to normal operating temperature) appear on the generator screen.The delivery device overheated; therefore, it was disconnected from the generator.The case was not completed and there were no patient complication.However, the patient had already being administered zofran, spinal anesthesia and antibiotic.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Manufacturer Narrative

Investigation summary: with all the available information, boston scientific concludes that the reported specific message error could not be replicated; therefore, the event cannot be confirmed.However, analysis did identify error code 219 (faulty delivery device on generator) upon priming.The delivery device backplate was opened and found the coil burnt.Based on information available it is probable that the burn coil likely contributed to the identified error code during priming.The cause of the reported event that led to aborting the procedure, could be traced back to the burnt coil component.Device history record (dhr): the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the product was returned for analysis to our post market quality assurance laboratory.Visual analysis revealed the delivery device handle was in overall good physical condition.The external tubing had no kinks.The resonant frequency (rf) connecting cable was in good physical condition.The pins in the connector were clean and straight.The delivery device buttons were pressed and spring back 5 times without.During functional testing, the retract/deploy functionality and the feel of the buttons were tested; however, starting prime error code 219 (faulty delivery device on generator) occurred.The backplate and top housing of the delivery device were removed for internal visual inspection; device internal appeared normal except for the coil which appeared burnt.The delivery device could not complete priming and pretreatment sequence due to the observed damage to the coil.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 that the guidance in the ifu was not followed.Investigation conclusion: based on the analysis results and information available, the reported event is confirmed.A conclusion code of cause traced to component failure was assigned to this investigation.

Event Description

It was reported that the staff started to do the injection with the delivery device, when an error message (wait for delivery device to cool to normal operating temperature ) appear on the generator screen.The delivery device overheated; therefore, it was disconnected from the generator.The case was not completed and there were no patient complication.However, the patient had already being administered zofran, spinal anesthesia and antibiotic.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 13096329
• MDR Text Key: 282910219
• Report Number: 2124215-2021-38883
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: KU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2022
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0025765569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 70 KG