MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC VPAD PATIENT TRACKER

Model Number	INS-0050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr.Was unable to successfully complete registration.The case did not continue past this point.They were unable to complete registration so they aborted the procedure entirely.This was a perc case, so they did not complete the case without veran.The patient was already under anesthesia.They were woken up and a follow-up procedure was scheduled.Technical support was contacted before the procedure was aborted and they were unable to fix the issue.After the procedure was aborted, technical support followed up and it was determined that the issue was most likely issues with the ct scan.It was prone and the orientation was incorrect.
Additional Manufacturer Narrative
This report is being supplemented to correct information provided in the initial medwatch report, and to provide additional information that was inadvertently not provided in the initial report.Correction to b4 of initial report: date of this report was 25-apr-2021.Correction to g3 of initial report: date received by manufacturer was 22-mar-2021.The subject device was not returned for evaluation.The investigation determined that the cause of the reported issue was due to the patient's computed tomography (ct) scan not being performed to veran protocol.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: VPAD PATIENT TRACKER
• Common Device Name: PATIENT TRACKER
• 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: 11721780
• Report Number: 3007222345-2021-00001
• Device Sequence Number: 3998716
• Product Code: JAK
• UDI-Device Identifier: 00815686020408
• UDI-Public: 00815686020408
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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 Model Number: INS-0050
• Device Catalogue Number: INS-0050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/01/2021
• Initial Report FDA Received Date: 04/25/2021
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SFT-0011 SPIN DRIVE SOFTWARE APPLICATION
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown