MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN THORACIC NAVIGATION SYSTEM / AOTT 22GA ANSO FLEXIBLE NEEDLE

Model Number SYS-3000/INS-5410

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

Patient Problem Blood Loss (2597)

Event Date 02/28/2020

Event Type  Injury  

Event Description

Patient was intubated.We began registering for navigation with a 22 gauge needle.Physician and his fellow began navigating, found the target and took one sample.Target was partially visible through the scope view and was bleeding before the sample was taken.Needle was removed and we waited a few minutes for the nurse to bring cytolite and slides in the room for the retrieval of samples.Physician began to clean up the airway before inserting the needle again when the nurse anesthetist began to ventilate the patient frantically.Other physicians came in, re-intubated her and started chest compressions.Vmt representative then stepped out of the room.When vmt representative returned the patient had been resuscitated and an a line was inserted in her arm.There was only room temperature saline in the room.The therapeutic scope was not brought in the room until after the event and there was no epinephrine or cold saline readily available at the time of increased bleeding.(they discussed this in the debriefing).Patient was stabilized, could open her eyes, squeeze the anesthesiologists hand before being sedated with propofol and sent to the icu.Follow up confirmed that the patient fully recovered.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM / AOTT 22GA ANSO FLEXIBLE NEEDLE
• Type of Device: SPIN THORACIC NAVIGATION SYSTEM / AOTT 22GA ANSO FLEXIBLE NEEDLE
• 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: 10092179
• MDR Text Key: 192185218
• Report Number: 3007222345-2020-00004
• Device Sequence Number: 1
• Product Code: JAK
• 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: 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
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2022
• Device Model Number: SYS-3000/INS-5410
• Device Catalogue Number: SYS-3000/INS-5410
• Device Lot Number: 81451150914/03923190703
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR