MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN PLANNING SOFTWARE APPLICATION

Model Number	SFT-0010
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: software version 4.3.2.The hospital had a team working on the issue.The veran representative was on-site again on april 5, 2023.At that time, the facility confirmed the issue had been resolved.It was an internal hospital network change that disrupted the workflow.There was no malfunction of any veran devices.
Event or Problem Description
A veran respiratory territory manager was on-site at the user facility and reported the following event.The computed tomography (ct) images were unable to transfer over to the spin planning laptop that was on the hospital's domain.Veran technical support (vsupport) assisted with confirming the correct application entity (ae) title and went behind the software under firewalls and confirmed that private, public, and domain were selected for planning and spin.Vsupport was unable to adjust the windows defender firewall setting on or off because "the settings are being managed by vender application trellix endpoint security firewall".The planning laptop was powered off and back on after the changes were made.The ct images were still unable to be transferred to the planning laptop.As the ct images were unable to transfer over to the spin planning laptop, the procedure was converted to an endobronchial ultrasound bronchoscopy (ebus) and radial ebus, rather than using the veran spin thoracic navigation system.The conversion of the procedure from peripheral bronchoscopy with electromagnetic navigation to an ebus would result in significant additional time under anesthesia.This report is being submitted for the prolonged surgery.Additional information was received that confirmed the previous/last procedure on (b)(6) 2023, was completed without issue.The hospital had made some network changes in-between the previous procedure and the subject event.Veran was restricted from usb access, and approval was required to burn a cd to obtain the images.Once approval was granted, they were still unable to import the ct images using the cd drive, since that was also being blocked.

• Brand Name: SPIN PLANNING SOFTWARE APPLICATION
• Common Device Name: SOFTWARE
• 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 dr; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 16834770
• Report Number: 3007222345-2023-00022
• Device Sequence Number: 17857820
• Product Code: JAK
• UDI-Device Identifier: 00815686021085
• UDI-Public: 00815686021085
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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: SFT-0010
• Device Catalogue Number: SFT-0010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/28/2023
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYS-4000 SPIN THORACIC NAVIGATION SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown