MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN THORACIC NAVIGATION SYSTEM

Model Number	SYS-4000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed on a female and samples taken.No pneumothorax upon xray immediately after procedure, but a small one appeared while in recovery.Patient admitted and discharged two days later.Admission was also due to staying in0hose for oncology.Pneumothorax resolved quickly.
Additional Manufacturer Narrative
This report was originally submitted on november 23, 2020.The mfr report # was submitted with a duplicate number (3007222345-2020-00013).The submission of the report failed, but the failure was not noted.This report is being re-submitted upon discovery of the failure from (b)(6) 2020.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM
• Common Device Name: SPIN THORACIC NAVIGATION SYSTEM
• 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: 15229273
• Report Number: 3007222345-2022-00019
• Device Sequence Number: 4693329
• Product Code: JAK
• UDI-Device Identifier: 00815686020736
• UDI-Public: 00815686020736
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: SYS-4000
• Device Catalogue Number: SYS-4000
• Device Lot Number: 84974191219
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 08/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female