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

Model Number SYS-4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 02/07/2020

Event Type  Injury  

Event Description

The physician inserted the scope to do an airway inspection before beginning registration.During this time, the physician noticed that there was some blood in the trachea from intubation.The physician proceeded with the airway inspection and experienced some slight bleeding.The physician and veran representative went through registration with no problems.The physician navigated out to the target and took one bite with the serrated forceps.Immediately after the bite, the patient's stats dropped and they began bleeding heavily.The veran representative stepped out of the room while anesthesia and the physician worked to stabilize the patient.After a few minutes, the patient became stable again and the physician aborted the rest of the case.Veran representative spoke with the physician on (b)(6) 2020 when the representative was notified that the patient had to be admitted to the hospital after the case.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM
• Type of Device: SPIN THORACIC NAVIGATION SYSTEM
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis, mo
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis, mo
• Manufacturer Contact: christine hardin ; 1908 innerbelt business center; saint louis, mo ; 6598500
• MDR Report Key: 10092182
• MDR Text Key: 192184550
• Report Number: 3007222345-2020-00003
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686020101
• UDI-Public: 00815686020101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYS-4000
• Device Catalogue Number: SYS-4000
• Device Lot Number: 83652180907
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR