MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. SPIN DRIVE SOFTWARE

Model Number SFT-0011

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.There was no procedure playback available for review.Based on the available information, we are not able to determine if the reported issue was due to a malfunction of the device or due to other factors.No root cause could be determined.Veran will continue to monitor field performance for this device.This event is being reported as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.Software version 4.3.2.

Event Description

The intended procedure was a localization of a right upper lobe lung nodule.The staff called veran technical support during localization procedure with the patient scanned laterally with pads placed on the back.They were unable to complete automatic registration and therefore had to place the pads on the side and walk through vpad snapshot.When they were trying to collect the lumen points, the physician was stating that he was in the trachea but the points were collecting in the left lobe.They reset the point cloud multiple times and the issue persisted.They tried resetting the snapshot multiple times and collecting point cloud but that did not fix the issue.They attempted to trim the point cloud but they were unable to get a good fit.When looking at the planning data, they noticed that the field of view was cutting off the top sensors on the two main board pads, which is the main reason why they were unable to successfully get through automatic registration.There was a reported 30-minute delay during troubleshooting.Navigation was discontinued and the procedure was completed using ultrasound.Although there was no impact on the patient, this event is being reported due to the 30-minute procedure delay while the patient was under anesthesia.

• Brand Name: SPIN DRIVE SOFTWARE
• Type of Device: 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; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 17238743
• MDR Text Key: 318208706
• Report Number: 3007222345-2023-00057
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SFT-0011
• Device Catalogue Number: SFT-0011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other