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

Model Number SFT-0011

Device Problems Computer Software Problem (1112); Insufficient Information (3190)

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

Event Date 07/12/2022

Event Type  Injury  

Manufacturer Narrative

At the start of the case, the site representative noticed that when the field generator was placed over the patient, there was a lag on the field generator within the software as compared to when it was physically moved.Site rep confirmed no interference and the patient was not on a fluoro bed.The doctor was able to proceed with the case once the field generator was positioned correctly.During the case, the doctor stated that the software was inaccurate and that there were discrepancies between the ct scan and the patient's actual anatomy.The procedure was aborted.After the procedure, all connections and wiring of the system and the field generator were checked and it was confirmed that they were seeded appropriately.The field generator continued to lag even after troubleshooting.

Event Description

With a patient under anesthesia, the procedure was aborted.

Event Description

This medwatch report was submitted for the sft-0011 spin drive software application.A separate report was submitted for the sys-4000 spin drive thoracic navigation system on medwatch 3007222345-2023-00001.This event is related to user facility report #: (b)(4).

Manufacturer Narrative

This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report, to correct information provided in the initial report, and to provide the results of the investigation of the reported event.G3 of the initial medwatch report was blank.The date received by manufacturer was 12-jul-2022.Correction to h1: this was a serious injury due to the aborted procedure after the patient was under anesthesia.According to the investigation, it is typical for some lag to be observed while moving the field generator while vpad associations are not established.If the vpad does not fit the segmented coils or vpad snapshot, the system is trying to establish the correct vpad associations with every frame.This can lead to the movement of the field generator lagging in the aiming widget.Under this circumstance, the system is not providing any tip location (because it doesn't even know which sensor is which) so latency is not a risk.Based on the review of the downloaded case data, the registration used during the procedure looked acceptable, but the tip was on the edge of the circle when checking the secondary carina.This could explain the discrepancy between image and physical location.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 APPLICATIO
• 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: 16294607
• MDR Text Key: 308920614
• Report Number: 3007222345-2023-00002
• 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
• Report Date: 08/15/2023

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
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 02/12/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White