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

Model Number	SFT-0010
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A veran respiratory territory manager was on-site during the following event.The patient was scanned on a new computed tomography (ct) scanner that did not have the veran protocol properly set up.This was not realized until the start of the case when the ct images were loaded onto the planning station via a compact disc (cd).The slice thickness was too high, and the scans had red caution symbols.The physician was unable to proceed with planning due to the scans not being performed with the veran ct protocol.The patient was already under anesthesia.The site re-scanned the patient with the correct protocol, then the physician proceeded with planning as normal.The plan was successfully exported, and the case was completed.Tissue samples were able to be obtained for pathology.There was reportedly a 30-minute delay due to the issue.There was no injury to the patient.There was no malfunction of any veran device.Although there was no impact on the patient, this report is being submitted due to the 30-minute procedure delay.
Additional Manufacturer Narrative
D4: software version 4.3.2.It was determined that the patient had been scanned on a new ct scanner that did not have the veran protocol properly set-up.There was no malfunction of a veran device.

• Brand Name: SPIN PLANNING SOFTWARE APPLICATION
• Common Device Name: PLANNING 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: 17084222
• Report Number: 3007222345-2023-00026
• Device Sequence Number: 16880151
• Product Code: JAK
• UDI-Device Identifier: 00815686021085
• UDI-Public: 00815686021085
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/07/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 06/07/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 62 KG