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	Blood Loss (2597)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician inserted the scope to do an airway inspection before beginning registration.During this time, the physician noticed that there was some blood in the trachea from intubation.The physician proceeded with the airway inspection and experienced some slight bleeding.The physician and veran representative went through registration with no problems.The physician navigated out to the target and took one bite with the serrated forceps.Immediately after the bite, the patient's stats dropped and they began bleeding heavily.The veran representative stepped out of the room while anesthesia and the physician worked to stabilize the patient.After a few minutes, the patient became stable again and the physician aborted the rest of the case.Veran representative spoke with the physician on (b)(6) 2020 when the representative was notified that the patient had to be admitted to the hospital after the case.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM
• Common Device Name: SPIN THORACIC NAVIGATION SYSTEM
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis, mo
• MDR Report Key: 10092182
• Report Number: 3007222345-2020-00003
• Device Sequence Number: 14233603
• Product Code: JAK
• UDI-Device Identifier: 00815686020101
• UDI-Public: 00815686020101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2020

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: 83652180907
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 05/27/2020
• 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: Hospitalization
• Patient Age: 68 YR