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

Model Number SFT-0011

Device Problem No Apparent Adverse Event (3189)

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

Event Date 03/15/2023

Event Type  Injury  

Manufacturer Narrative

At this time, veran is not able to determine if the registration anomaly was due to lung anatomy, operator error, or another problem source.The investigation is still in progress.A supplemental report will be filed once the investigation is complete or if additional information is received.

Event Description

Event 2 of 2: the user facility reported that the doctor was attempting a second localization for the same patient after they could not get through registration on (b)(6) 2023, during the first attempt at localization.(the first event was reported to the fda by veran under medwatch 3007222345-2023-00008; and reported to the fda by the patient under medwatch mw5116020).The patient was undergoing a thoracic localization procedure.A veran representative was on-site for the procedure and veran's technical support team (vsupport) was contacted to assist with troubleshooting during the registration process.At the start of the case, both monitors were entering sleep mode.Vsupport had the on-site veran representative unplug and replug all cords on the back of the monitors and restart the spin thoracic navigation system.The system booted on as expected.The patient was laying left lateral decubitus with the vpads placed in a "t" formation on the right side of the patient.The system prompted an automatic registration.The main carina was off, so it was adjusted by clicking 'no' and then 'touch main carina'.When the doctor navigated to the secondary carina landmark that was placed on the left secondary carina, the software was showing that the instrument was entering the right lower lobe.Vpad placement was checked and all metal was removed from near the patient (there was a metal arm over the patient to hold their arm up, which is used in every veran case and has not been an issue in the past).Registration was then switched to 'vpad replace'.Doctor performed a snapshot and attempted to collect a point cloud, but the points were not collecting in the correct areas.The instrument cross-hairs was not following the actual location of the instrument.When the doctor navigated to what he stated to be the right lower lobe, the points were collecting in the right upper lobe.When the doctor navigated to what he stated to be the left lower lobe, the points were collecting in the right lower lobe.The trachea was collecting in the right main stem bronchus.Vsupport and the on-site veran representative confirmed the labels (rmb (right main bronchus), lmb (left main bronchus), and trachea) were correct from the planning application and that the scans were marked as non-supine.Vsupport and the on-site veran representative were unsuccessful in troubleshooting.The procedure was aborted and the patient was woken up from anesthesia.There was no patient harm reported.Although there was no patient harm reported, this event is being reported due to the patient being woken up from anesthesia and the procedure being cancelled.The subject patient has submitted mw5116021 to the fda on his behalf regarding this second event.See attached copy of mw5116021.

Manufacturer Narrative

This report is being supplemented to correct b4 of the first supplemental medwatch report that was submitted.B4: date of this report was documented as (b)(6) 2023; however, the mdr was actually submitted on (b)(6) 2023.

Manufacturer Narrative

This report is being supplemented to provide the results of the investigation of the reported event.The playback data was collected and used for the investigation.The investigation revealed that the image sensors and physical sensors were associated correctly.However, it did appear that the main carina and the secondary carina were not lined up correctly initially and the secondary carina did not line up well after performing a main carina touch.The point cloud collection worked as intended; however, a good fit was not achievable and the best fit that the iterative closest point (icp) algorithm found was far from optimal.Accuracy was far from acceptable after point cloud collection but the investigating engineer believes that was because the shape of the airways during point cloud collection was far from the shape of the airways during image acquisition.While unfortunate, the procedure setup task prevented the user from progressing to navigation with a poor registration.Based on the available information, there was no malfunction of the veran software.

• Brand Name: SPIN DRIVE SOFTWARE APPLICATION
• Type of Device: SOFTWARE APPLICATION
• 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: 16748287
• MDR Text Key: 313396906
• Report Number: 3007222345-2023-00021
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: SPIN THORACIC NAVIGATION SYSTEM.
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 81 KG