MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN DRIVE SOFTWARE APPLICATION; SFT-0011

Model Number SFT-0011

Device Problems Computer Software Problem (1112); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  Injury  

Event Description

The rep and the physician had a tough time getting registration to line up.The collected 4 point clouds and the accuracy was not up to the doctor's standards.The area of interest was on the edge of the secondary carina sphere and the doctor wanted it to be more within the circle more.The rep noticed there was a lot of motion in the expiration scan.The rep uploaded the inspiration scan as a referral and collected a 5th cloud.Registration looked more accurate after this so the doctor moved forward with the procedure and into navigation the doctor tried to navigate out of the patient, but was unable to reach the nodule.The doctor completed the procedure with a bal.There was a delay in procedure of 30 minutes.

Event Description

Additional information regarding the reported event: this event was reported due to the 30-minute procedure delay while the patient was under anesthesia.

Manufacturer Narrative

This report is being supplemented to provide information that was inadvertently not provided in the initial medwatch report and to provide the results of the investigation of the event.The procedure playback and data were reviewed.Based on the review, the point cloud collected did not match the computed tomography (ct) scan that was collected, demonstrating that there was anatomical shift between the time of the ct scan and the navigated procedure.The software correctly reported a registration error and warned the user.The investigation determined that the software functioned as intended.The user attempted to register and navigate for approximately 30 minutes before determing they were unable to reach the target.No evidence of a device malfunction.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.

• Brand Name: SPIN DRIVE SOFTWARE APPLICATION
• Type of Device: SFT-0011
• 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: 13048702
• MDR Text Key: 282548719
• Report Number: 3007222345-2021-00023
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SFT-0011
• Device Catalogue Number: SFT-0011
• Device Lot Number: 4.3.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other