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 Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

During an internal review of the mdr/ ae events for veran medical technologies over the last 36 months, it was determined that this ae failed to fully upload into the fda system through webtrader.The report was originally submitted on friday, 19-feb-2021 at 17:00:21.It failed to upload completely due to an error.This report is being resubmitted on 06-jun-2022 as 3007222345-2022-00017.

Event Description

Patient had preexisting heart issues and previous heart attack; cardiology had cleared her for the procedure.Patient was in prone position and the dr navigated out to lesion with forceps.The dr switched over to 22g needle, took one sample, and the patient started bleeding.The dr was able to get the bleeding under control but the pressure dropped and then patient coded.The patient suffered a heart attack and was stabilized in room.The patient was transported to ccu and was released from the hospital days later.

Manufacturer Narrative

This report is being supplemented to provide information that was inadvertently not provided in the initial medwatch report, and to correct information provided in the initial report.Correction to b4 of initial medwatch report: date of this report was 06-jun-2022.G3: date received by manufacturer was blank on the initial medwatch report and should have been 21-jan-2021.Correction to h4 of initial medwatch report (see h4).The investigation of the event concluded that the complaint issue was related to the patient's pre-existing conditions, not due to a failure of any veran 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.

• Brand Name: ALWAYS-ON-TIP TRACKED 22GA FLEXIBLE NEEDLE
• Type of Device: 22GA 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: 14605112
• MDR Text Key: 293448835
• Report Number: 3007222345-2022-00017
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Model Number: INS-5410
• Device Catalogue Number: INS-5410
• Device Lot Number: 04593200615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• 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
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 79 KG