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 Pneumothorax (2012)

Event Date 10/26/2020

Event Type  Injury  

Event Description

Procedure performed on a female and samples taken.No pneumothorax upon xray immediately after procedure, but a small one appeared while in recovery.Patient admitted and discharged two days later.Admission was also due to staying in0hose for oncology.Pneumothorax resolved quickly.

Manufacturer Narrative

This report was originally submitted on november 23, 2020.The mfr report # was submitted with a duplicate number (3007222345-2020-00013).The submission of the report failed, but the failure was not noted.This report is being re-submitted upon discovery of the failure from (b)(6) 2020.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM
• Type of Device: SPIN THORACIC 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: 15229273
• MDR Text Key: 297948467
• Report Number: 3007222345-2022-00019
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686020736
• UDI-Public: 00815686020736
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2022

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
• Device Operator: Health Professional
• Device Model Number: SYS-4000
• Device Catalogue Number: SYS-4000
• Device Lot Number: 84974191219
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 08/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female