MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN THORACIC NAVIGATION SYSTEM

Model Number	SYS-4000
Medical Device Problem Codes	Computer Software Problem (1112); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
With a patient under anesthesia, the procedure was aborted.
Additional Manufacturer Narrative
At the start of the case, the site representative noticed that when the field generator was placed over the patient, there was a lag on the field generator within the software as compared to when it was physically moved.Site rep confirmed no interference and the patient was not on a fluoro bed.The doctor was able to proceed with the case once the field generator was positioned correctly.During the case, the doctor stated that the software was inaccurate and that there were discrepancies between the ct scan and the patient's actual anatomy.The procedure was aborted.After the procedure, all connections and wiring of the system and the field generator were checked and it was confirmed that they were seeded appropriately.The field generator continued to lag even after troubleshooting.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report, to correct information provided in the initial report, and to provide the results of the investigation of the reported event.G3 of the initial medwatch report was blank.The date received by manufacturer was 12-jul-2022.Correction to h1: this was a serious injury due to the aborted procedure after the patient was under anesthesia.According to the investigation, it is typical for some lag to be observed while moving the field generator while vpad associations are not established.If the vpad does not fit the segmented coils or vpad snapshot, the system is trying to establish the correct vpad associations with every frame.This can lead to the movement of the field generator lagging in the aiming widget.Under this circumstance, the system is not providing any tip location (because it doesn't even know which sensor is which) so latency is not a risk.Based on the review of the downloaded case data, the registration used during the procedure looked acceptable, but the tip was on the edge of the circle when checking the secondary carina.This could explain the discrepancy between image and physical location.Veran will continue to monitor field performance for this device.This supplemental report is being submitted as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.
Event or Problem Description
This medwatch report was submitted for the sys-4000 spin thoracic navigation system.A separate report was submitted for the sft-0011 spin drive software application on medwatch 3007222345-2023-00002.This event is related to user facility report #(b)(4).

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM
• Common Device Name: THORACIC NAVIGATION SYSTEM
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: jennifer andre ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 16294622
• Report Number: 3007222345-2023-00001
• Device Sequence Number: 15342079
• Product Code: JAK
• UDI-Device Identifier: 00815686020101
• UDI-Public: 00815686020101
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: SYS-4000
• Device Catalogue Number: SYS-4000
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/12/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White