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 02/01/2023

Event Type  Injury  

Manufacturer Narrative

Veran reviewed the diagnostic case data provided by the hospital for this procedure.A confirmation was also made that the image to physical vpad associations were made correctly during the procedure.In review of the data collected, veran was not able to determine if the registration anomaly was due to lung anatomy, operator error, or another problem source.Investigation is still in progress and a supplemental report will be filed once the investigation is complete or if additional information is supplied.

Event Description

Patient was undergoing a thoracic localization procedure.A veran representative was on-site for the procedure and veran's technical support team was contacted to assist with troubleshooting during the registration process.After multiple attempts to troubleshoot the registration issue, the doctor was unable to register the patient accurately and decided to not move forward with the procedure.Patient's procedure was reportably rescheduled for (b)(6) 2023.There was no patient harm reported.Additional information has been requested.

Manufacturer Narrative

This report is being supplemented to correct information provided in previous submissions and to provide additional information.B4: for 3007222345-2023-00008 follow-up medwatch report #1, field b4 was incorrectly reported as 04-apr-2023; the correct date was 05-apr-2023.

Event Description

The reported event was initially submitted as a product problem.Although there was no patient harm reported, this event was reassessed and determined to be an adverse event due to the procedure being aborted after the patient was under anesthesia, and the procedure being rescheduled to a future date.This is event 1 of 2.Event 2 was reported on medwatch 3007222345-2023-00021.

Manufacturer Narrative

This report is being supplemented to provide additional information received from the customer regarding the reported event, and to link mw5116020 to the reported event.

Event Description

Additional information was received from the customer regarding the reported event.The doctor confirmed that the patient was under general anesthesia at the time of the event.There was no impact on the patient, other than the inconvenience and stress of needing to be rescheduled.At the time of receiving the additional information, the device had not been used since the reported event.Since the submission of the initial medwatch report, the subject patient has submitted mw5116020 on his behalf regarding the reported event.See attached copy of mw5116020.The patient referred to a second event in mw5116020 that was also submitted by the patient on his behalf under mw5116021.The details of the second event will be reported by veran in a future medwatch report.

Manufacturer Narrative

This report is being supplemented to provide the results of the investigation of the reported event.In viewing the diagnostic case data, it was confirmed that the computed tomography (ct) scans were performed in a non-supine orientation.During the viewing of the playback, the engineers were able to confirm that the vpads were registering correctly, but the physical airways were not aligned with the ct image airways.Registration problems where navigation does not register to the proper airway can be a result of shifting of one or more of the vpads between the time of the ct scan and the time of the patient's procedure.Registration problems can also be due to the patient's respiration during the procedure not passing through the same point in the respiratory cycle as where the ct scan was acquired (e.G., ct scan was acquired at extreme inspiration and patient breathing is shallow during the procedure).

• 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; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 16482617
• MDR Text Key: 310730721
• Report Number: 3007222345-2023-00008
• 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,Followup,Followup,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• 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: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 81 KG