MAUDE Adverse Event Report: AURIS HEALTH, INC. MONARCH PLATFORM; BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES

Model Number	ASMITH6@ITS.JNJ.COM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a monarch-assisted bronchoscopy procedure due to concerns for potential pneumothorax (high peak pressure and declining 02 saturations).The physician obtained a portable chest x-ray (cxr) and a left sided pneumothorax was noted.The physician proceeded to place a 14g wayne pneumothorax chest tube at the bedside.The patient was admitted for observation.The chest tube was removed, and the patient was discharged the following day.
Additional Manufacturer Narrative
This event was reported from the transbronchial biopsy assisted by robot guidance in the evaluation of tumors of the lung (target) study (b)(6).The device was not returned for evaluation.There was no allegation of device failure.Risk of pneumothorax is documented in (b)(4), rev f, monarch bronch risk management report and is deemed to be acceptable.Based on the information available for this complaint, the root cause of the reported event is related to a known inherent risk of the device and procedure as documented in the labeling.
Additional Manufacturer Narrative
Engineering confirmed that the logs of the reported event were not being uploaded to the cloud.Three good faith efforts (gfe) were made acquiring the logs.However, the logs have not become available as of 7/18/2022.Due to the absence of logs, a full failure analysis cannot be performed against the system.A review of the device history record (dhr) was performed.There are no reports of nonconformance that relate to the reported incident.A review for similar complaint shows the reported issue is a known issue however the root cause is specific to each individual case.Risk of pneumothorax is documented in 105-000299-01, rev f, monarch bronch risk management report and is deemed to be acceptable.This issue will be tracked and trended in the monthly complaint trend review meetings.

• Brand Name: MONARCH PLATFORM
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA 94065
• Manufacturer (Section G): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA 94065
• Manufacturer Contact: andria smith ; 150 shoreline drive; redwood city, CA 94065
• MDR Report Key: 14700731
• Report Number: 3014447948-2022-00008
• Device Sequence Number: 5175357
• Product Code: EOQ
• UDI-Device Identifier: B634MON000005010
• UDI-Public: +B634MON000005010/16D20210922
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K193534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Model Number: ASMITH6@ITS.JNJ.COM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female