MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC ALWAYS-ON TIP TRACKED 22GA FLEXIBLE NEEDLE

Model Number INS-5410

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

Patient Problems Airway Obstruction (1699); Pneumothorax (2012); Cough (4457)

Event Date 04/20/2021

Event Type  Injury  

Event Description

Patient had a difficult ggl in the rml.The nodule had no defined airway to it.Registration was good and no issues.The doctor was able to navigate and get there with the forceps.He had rose in the room.They confirmed atypical cells.Dr then proceeded to use the 22ga needle.Dr took approx.3 needle biopsies which resulted in a malignant call from rose.While using the needle, manufacturer rep was in the room and noted to the doctor that he had advanced past the nodule and was near the pleura and to pull back.After the 22ga he used the triple needle brush.He made 1 pass with the triple needle brush.After that the patient started coughing and bucking.He wanted to go back and get more forceps samples but the airways on our tower weren't matching the actual airways of the patient.We went to go back to re register and he decided he had enough samples and finished the case.Once the patient woke from the anesthesia, dr.Noticed something was wrong.Patient was brought immediately back into the room and a chest tube was placed.Patient recovered and released.

Manufacturer Narrative

This report is being supplemented to correct information provided in the initial medwatch report, to provide additional information regarding the reported event (b5), and to provide information that was inadvertently not provided in the initial medwatch report.Correction to g3 of the initial medwatch report: date received by manufacturer was 20-apr-2021.The subject device was not returned, as the device was disposed of by the facility.There was no allegation of device malfunction.The veran representative that was present for the reported event alerted the physician that he was past the nodule and close to the pleura while sampling with the needle.The veran representative advised pulling back the instrument to avoid the pleura.A pneumothorax is a known risk of the device and the procedure.Veran will continue to monitor field performance for this device.This supplemental report is being submitted as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.

Event Description

Clarification regarding the reported event: the patient developed a pneumothorax that required placement of a chest tube.Grade was 100% pneumothorax with tension.

• Brand Name: ALWAYS-ON TIP TRACKED 22GA FLEXIBLE NEEDLE
• Type of Device: FLEXIBLE NEEDLE
• 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: 11721779
• MDR Text Key: 247213481
• Report Number: 3007222345-2021-00009
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686020637
• UDI-Public: 00815686020637
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: INS-5410
• Device Catalogue Number: INS-5410
• Device Lot Number: 04118191016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FORCEPS - MODEL UNKNOWN.; INS-5300 ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH.; SYS-4000 SPIN THORACIC NAVIGATION SYSTEM.
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female