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 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The procedure playback data was not provided for review.Based on the available information, we are unable to determine if there was a malfunction of the device or if the reported event was due to other issues.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.D4: software version 4.3.1.

Event Description

A veran representative was present during the following event.During planning, the nodule was off so they had to do a mapping refinement.During registration, they had to collect points and do a trim point cloud.While they were doing the percutaneous procedure, the needle looked like it was further into the skin than it actually was.Once they were in the lung, they were able to see that the needle and dye marking were off, as the dye marking was on the wrong lobe of the lung.Although there was no reported impact on the patient or the procedure, this event is being reported due to the allegation of device inaccuracy.

Manufacturer Narrative

This report is being supplemented to correct information provided in the initial medwatch report.B4: date of this report was incorrectly reported as 13-aug-2021.The correct b4 should have been 30-jun-2023.

• 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: 17239902
• MDR Text Key: 318221627
• Report Number: 3007222345-2023-00062
• 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
• Report Date: 07/19/2023

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?: No
• 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: 07/19/2023
• 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