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 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.User review of mapping in planning did not identify the issue.There are specific steps within the software application for the user to confirm mapping.There are tools available to adjust, if needed.Based on the available information, a root cause for the reported issue could not be determined.Confirmation was received that the facility continued to use the navigation system after the reported event.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

The physician felt that the path to the lesion in planning was different than what was given in the software.The physician sampled the lesion during the procedure and the system looked spot on, but pathology was coming back with a benign result.The physician went down to confirm with radial endobronchial ultrasound (ebus) and was able to show the veran representative that the lesion was in a different airway and began to sample that area.The pathology came back as suspicious material.There was no impact on the patient as a result of the reported issue.

• 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: 17239896
• MDR Text Key: 318220436
• Report Number: 3007222345-2023-00061
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686021221
• UDI-Public: 0100815686021221
• 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
• Report Date: 06/30/2023

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: 02/16/2021
• 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