MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC ALWAYS-ON TIP TRACKED 21GA ANSO CYTOLOGY NEEDLE; BIOPSY NEEDLE

Model Number	INS-0392
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Veran has attempted to contact the initial reporter twice via email to acquire additional information.There has been no response by the initial reporter as of the date this report is being submitted.The initial reporter indicated in mw5114915 that the device was available for evaluation, however the device has not been provided to veran as of the date this report is being submitted, and we have not received confirmation from the risk manager that the device is available.The investigation is in-progress.Once the investigation is complete, or if additional information is received, this report will be supplemented accordingly.
Event or Problem Description
Medwatch report (mw5114915) was received from the fda on 21-feb-2023.The medwatch report was submitted by a risk manager at the user facility.The following description was included in the report."during a navigational bronchoscopy with the veran there was an issue with the always-on tip tracked 21g anso cytology needle.The needle on the product would not retract back into the sheath after a few uses.This malfunction resulted in discontinued use of the product and limited specimens." based on the information provided in the medwatch report submitted by the risk manager, there was no impact on the patient as a result of the reported issue.
Additional Manufacturer Narrative
This report is being supplemented to provide the results of the investigation of the reported issue.The device was discarded by the hospital; therefore, there could not be an investigation of the specific failure mode.The risk summary describes the risk associated with a device that is kinked or unable to retract.The cause of this failure mode is typically from damage to the pull wire caused by torquing or pushing the device too much during operation.In this case, the failure occurred after removing the sample from the needle, which indicates the needle was not exposed within the patient.As the device was not returned for evaluation, a definitive root cause could not be determined.

• Brand Name: ALWAYS-ON TIP TRACKED 21GA ANSO CYTOLOGY 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 dr; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 16607064
• Report Number: 3007222345-2023-00016
• Device Sequence Number: 12299256
• Product Code: JAK
• UDI-Device Identifier: 00815686020613
• UDI-Public: 00815686020613
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: 03/08/2024
• Device Model Number: INS-0392
• Device Catalogue Number: INS-0392
• Device Lot Number: 04990210223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPIN THORACIC NAVIGATION SYSTEM.
• Patient Sex: Unknown