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	02/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician planned the procedure without issue.The adverse event took place during the navigation portion of the procedure.The physician performed a manual registration using the serrated forceps.After collecting lumen points, the locations of both the main and secondary carinas were verified and accurate.The physician then proceeded to the navigation portion of the procedure.He was after a large 3-4cm mass in the right upper lobe.Initially, the physician began sampling with the 22ga needle.He took 3-4 samples on the inferior and lateral border of the nodule.The physician noted that the needle was "slipping" when he went to deploy in the desired location.Thus, he switched to a more rigid 19ga needle.After navigating to the desired location, he took a sample from the area of interest in what appeared to be the center of the nodule.As the nurse in the room was extracting the sample from the needle, the physician noted the patient started to bleed profusely and lacked a tidal sign during respiration.He administered cold saline/lidocaine in an attempt to control the bleeding-both methods were unsuccessful.At this point, the physician called the anesthesiologist as well as other physicians to help stabilize the patient.The patient crashed, at which point the anesthesiologist administered chest compressions.Another physician re-intubated the patient with a double-lumen tube.Defibrillator pads were placed, but never used, as the chest compressions/double-lumen tube normalized the patient's vitals.Upon x-ray, it was determined the patient suffered a fractured rib as a result of the chest compressions.The physician performed a therapeutic bronchoscopy and the patient was transferred to the icu.At this point, the veran representative left the site.Patient outcome: fx'd rib/severe lung bleed that required hospitalization in the icu.Updated information: patient recovered and was discharged.

• 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: 10092181
• Report Number: 3007222345-2020-00002
• Device Sequence Number: 19663365
• 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): 03/14/2020

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: 83422180625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• 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: 80 YR