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

Model Number	INS-5410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3007222345-2022-00017
• Device Sequence Number: 5077265
• Product Code: JAK
• UDI-Device Identifier: 00815686020637
• UDI-Public: 00815686020637
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 79 KG