MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC ALWAYS-ON TIP TRACKED 19GA HISTOLOGY NEEDLE, 15MM L, 1.8MM OD; ENDOBRONCHIAL NEEDLE

Model Number	INS-0382
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not returning to veran for further evaluation, as the needle was discarded by the hospital.
Event or Problem Description
A veran product manager was on-site during a bronchoscopy and bronchoalveolar lavage (bal) procedure and reported that after three passes, the ins-0382 endobronchial needle (always-on tip tracked 19ga histology needle, 15mm l, 1.8mm od) would no longer retract back into its sheath after the extracted tissue sample was placed in the collection container.The issue did not occur while the needle was in the patient or in the bronchoscope.A 21ga endobronchial needle was opened for additional sampling.A brush was also opened for cytology samples the procedure was completed.There was no impact to the patient or the procedure as a result of the reported issue.
Additional Manufacturer Narrative
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 19GA HISTOLOGY NEEDLE, 15MM L, 1.8MM OD
• Common Device Name: ENDOBRONCHIAL 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: 16739375
• Report Number: 3007222345-2023-00019
• Device Sequence Number: 6862881
• Product Code: JAK
• UDI-Device Identifier: 00815686020590
• UDI-Public: 0815686020590
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: 06/16/2023
• Device Model Number: INS-0382
• Device Catalogue Number: INS-0382
• Device Lot Number: 04595200603
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• 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: Male