MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. SPIN THORACIC NAVIGATION SYSTEM, 230V, 50HZ

Model Number	SYS-4230-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012); Respiratory Failure (2484)
Type of Reportable Event	Serious Injury
Event or Problem Description
Journal article: diagnostic yield and safety of biopsy guided by electromagnetic navigation bronchoscopy for high-risk pulmonary nodules.Publication date: february 24, 2021.Background: electromagnetic navigation bronchoscopy (enb) is a useful method to obtain tissue for peripheral lung nodules.We aimed to understand the diagnostic yield and safety profile in high-risk pulmonary nodules that cannot be accessed by percutaneous transthoracic needle biopsy.Based on the article, there were seven (7) adverse events documented: -there were four (4) patients that exhibited moderate bleeding that required cold saline and topical epinephrine.One (1) of the four (1) patients experienced respiratory failure that required intubation due to obstruction of the bronchus by a blood clot.-there were three (3) patients that developed a pneumothorax.One (1) of the three (3) patients required a chest tube insertion.There was no allegation or information to suggest there was an associated malfunction of a veran device.
Additional Manufacturer Narrative
B3: date of event - procedures were performed between october 2018 and may 2020.Pneumothorax and bleeding are known risks of the device and the associated procedure(s).Refer to the journal article attached to this submission.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM, 230V, 50HZ
• 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: 17279610
• Report Number: 3007222345-2023-00077
• Device Sequence Number: 11632981
• Product Code: JAK
• UDI-Device Identifier: 00815686020101
• UDI-Public: 00815686020101
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,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-4230-K
• Device Catalogue Number: SYS-4230-K
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown