MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN THORACIC NAVIGATION SYSTEM

Model Number	SYS-3000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Veran is submitting this mdr as part of an overall retrospective review in response to an fda form 483 that was issued to the firm as of january 2019.
Event or Problem Description
System performed as intended; no malfunction.Doctor found that even when we were in the nodule on navigation, there was no visible lesion in he airways so the forceps would have not yielded anything but bronchial epithelial cell.Doctor then switched to the 22ga needle to go for the target outside of the airway for a few samples.Now that he had a general idea of where the nodule was, he switched over to cryo to get 3 samples with the cryo probe in conjunction with an airway balloon blocker to control bleeding.Grade 3 bleeding indicated.

• 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 63114
• MDR Report Key: 9401536
• Report Number: 3007222345-2019-00014
• Device Sequence Number: 19641268
• Product Code: JAK
• UDI-Device Identifier: 00815686020088
• UDI-Public: 00815686020088
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K122106
• 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): 11/27/2019

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
• Device Lot Number: 81373150715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 12/03/2019
• 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: Other