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

Model Number	MON-000005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Pneumothorax (2012)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
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 19-br-0001 (nct04182815).The device was not returned for evaluation.There was no allegation of device failure.Risk of pneumothorax is documented in 105-000299-01, 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.Serial number: (b)(4).
Event or Problem Description
It was reported that a patient with a history of lupus and a recent bronchoscopy for a biopsy of the left lung nodule returned to the hospital the following morning for pain in the left chest and requested a chest x-ray for further evaluation.The patient denies shortness of breath but reports increased pain with deep breathing.The patient did have a post procedure x-ray done following the procedure which showed no pneumothorax.The patients pain started on the way home from the procedure the previous day.A thora vent was placed into the left chest.Suctioning was used for about an hour.A repeat x-ray at that time showed near complete resolution of the pneumothorax on the left.The patient continued to feel well and was not hospitalized.The patient returned the following day to have the thora vent removed and reported tolerated the device well, no shortness of breath as well as no significant left chest pain.
Additional Manufacturer Narrative
The follow-up report is be submitted to relay additional information.The following sections were updated: there were no device malfunctions reported from the procedure.A device history record (dhr) review was performed for system 110024 and there were no non-conformances related to the pneumothorax reported in this case.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.No corrective action is required at this time.The reported event will continue to be monitored through regular complaint trend review.The follow-up report is be submitted to relay corrected information.The following sections were updated: g3, g4 g3: 09/12/2022.G4: k173760.

• 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 ; 5745510671
• MDR Report Key: 15298112
• Report Number: 3014447948-2022-00024
• Device Sequence Number: 17647976
• Product Code: EOQ
• UDI-Device Identifier: B634MON0000050
• UDI-Public: +B634MON0000050/16D20190304
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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: MON-000005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male