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

Model Number	INS-5410
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor was navigating to her second target after taking 10 passes to target 1 with the needle.She noticed on her scope view that the needle was coming out of the distal end of the sheath while the tech had it retracted and in the locked position.After they removed the instrument from the scope, they could see that the needle was detached from the pole wire.
Additional Manufacturer Narrative
At the time of this report, the device had not been returned for investigation.Procedure was completed and there was no injury to the patient.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report.G3 was blank in the initial medwatch report.Date received by manufacturer was 17-aug-2022.The subject device was not returned for evaluation, as it was discarded by the facility.A root cause could not be determined.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.

• Brand Name: ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE
• Common Device Name: BIOPSY 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: 15422574
• Report Number: 3007222345-2022-00022
• Device Sequence Number: 11399281
• Product Code: JAK
• UDI-Device Identifier: 00815686020637
• UDI-Public: 00815686020637
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2023
• Device Model Number: INS-5410
• Device Catalogue Number: INS-5410
• Device Lot Number: 04593200625
• 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: 11/04/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2020
• 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
• Patient Sex: Unknown