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	Tachycardia (2095)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Planned for a rll segmented 22mm target with 8.3mm of motion in what physician said was the superior basal segment of a (b)(6) y/o male.During registration with a 21ga needle, the main carina was adjusted with "touch main carina".The secondary was considered accurate as the instrument's crosshair was in the center of the blue bullseye in the ct views.He continued navigating with the needle and found a bit of a difficult trajectory.He took two samples and was going to switch to forceps.After about 4 minutes of downtime switching instruments to the forceps and moving monitors, the rn, said they were going to wait for the patient's heart rate to slow back down.After a couple of minutes, she asked if the vpads would inhibit ekg leads.They took an ekg and made the decision to send the patient to the cath lab.When asked about bleeding verse heart issues.She said, "no, no bleeding.Everything is okay we're just sending them to the cath lab." case was ended.

• 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: 10092176
• Report Number: 3007222345-2020-00005
• Device Sequence Number: 19613546
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/01/2020

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: 84446190731
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• 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: 61 YR