MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN THORACIC NAVIGATION SYSTEM; SYS-4000

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	01/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During a case on (b)(6) 2020 the physician declined veran representitive's offering of the triple needle brush citing that he had used the product in a previous case where the patient resulted in a pneumothorax.Veran representitive reported incident to vsupport 03-june-2020, and additional information was requested from the physician.Veran representitive contacted physician three times and received a response 17-june-2020.Physician responded, "that's only one time so i don't restrict myself to use for the future.Emphysema pts do have risk of pneumothorax so i'll give future chance to triple brush.Pt did very well after chest tube placement." follow-up reported on 18-jun-2020 - case was held (b)(6) 2020 - patient had ct guided biopsy completed at deaconess midtown.A pneumothorax occured and a chest tube was administered.Patient was stabilized.Veran representative met with a member of the respiratory therapist team who showed the representative the patients file.The ct guided pneumothorax and chest tube placement was documented.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM
• Common Device Name: SYS-4000
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis, mo
• MDR Report Key: 10228672
• Report Number: 3007222345-2020-00007
• Device Sequence Number: 3143052
• 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): 07/02/2020

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 Expiration Date: 07/12/2018
• Device Model Number: SYS-4000
• Device Catalogue Number: SYS-4000
• Device Lot Number: 83472180712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 07/03/2020
• 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: 62 YR