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 05/25/2017

Event Type  Injury  

Manufacturer Narrative

Veran is submitting this mdr as part of an overall retrospective review in response to an fda form 483 what was issued to the firm as of january 2019.

Event Description

System performed as intended; no malfunction.Began with ebus and then switched to navigation.Took a couple of passes with 22ga needle, but both returned bloody slides.Case aborted shortly afterwards because of excessive bleeding.Insufficient information regarding treatment for bleeding.

• 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 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: christine hardin ; 1908 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 9401572
• MDR Text Key: 168813066
• Report Number: 3007222345-2019-00007
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• 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: 82965171207
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2017
• 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): Other