MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. IG4 SYSTEM, 120V, 60HZ; NAVIGATION SYSTEM

Model Number	SYS-3000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012)
Type of Reportable Event	Serious Injury
Event or Problem Description
Journal article: peripheral lung nodule diagnosis and fiducial marker placement using a novel tip-tracked electromagnetic navigation bronchoscopy system.Published january 2019.Background: electromagnetic navigation (emn) has improved bronchoscopic access to peripheral pulmonary nodules.A novel emn system utilizing novel tip-tracked instruments for endobronchial [electromagnetic navigation bronchoscopy (enb)] as well as transthoracic lung biopsy [electromagnetic-guided transthoracic needle aspiration (emttna)] has become available.The system provides real-time feedback as well as the ability to biopsy lesions outside of the airway.These advances have the potential to improve diagnostic yield over previous emn systems.Based on the article, there were four (4) adverse events documented: - there were three (3) patients that developed a pneumothorax that required small-bore chest tube placement with an observation admission (<24 hours).- there was one (1) patient that developed a hemorrhage that required bronchoscopic wedging and iced saline to achieve hemostasis.The patient was subsequently discharged home.There was no allegation or information to suggest there was an associated malfunction of a veran device.
Additional Manufacturer Narrative
Date of event - procedures were performed between june 2015 and april 2017.The journal article refers to a "spindrive tip tracked instrument emn system".Based on the timing of the described events, it is likely the device was an sys-3000 ig4 system, 120v, 60hz.Pneumothorax and bleeding are known risks of the device and the associated procedure(s).Please refer to the journal article attached to this submission.

• Brand Name: IG4 SYSTEM, 120V, 60HZ
• Common Device Name: 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: 17278847
• Report Number: 3007222345-2023-00076
• Device Sequence Number: 3493672
• Product Code: JAK
• UDI-Device Identifier: 00815686020088
• UDI-Public: 00815686020088
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K122106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: SYS-3000
• Device Catalogue Number: SYS-3000
• 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: 06/08/2023
• Initial Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown