MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH, 12MM L, 1.8MM OD; BIOPSY BRUSH

Model Number	INS-5300
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a navigational bronchoscopy procedure, the doctor experienced a triple needle brush (ins-5300: always-on tip tracked triple needle brush, 12mm l, 1.8mm od) not fulling retracting back into the sheath.This was noticed before it ever entered the scope/patient.Another triple needle brush was opened to complete the case, but this second triple needle brush experienced the same issue.A 21 ga needle was then opened to complete the case.The intended procedure was able to be completed after a minor delay of 2 minutes.There was no impact on the patient or the procedure.This mdr is being submitted for the issue with the first triple needle brush.The issue with the second triple needle brush is being submitted under medwatch 3007222345-2023-00028.
Additional Manufacturer Narrative
The subject device is expected to be returned to veran for evaluation.The device has not yet been received.This report will be supplemented if additional information is received.
Additional Manufacturer Narrative
This report is being supplemented to correct information provided in the initial report and to provide the results of the investigation of the reported event.Correction to h4: device manufacture date.The subject device was not returned for evaluation; therefore, there could not be an investigation of the specific failure mode.A short sheath, component dimensions not within specification, or assembly errors are potential causes for the brush tip to be exposed.In addition, the length of the pull wire that connects the push needle in the handle to the triple needle brush may be too long.The potential cause includes damage to the instrument, including bending/kinking during shipping.As the device was not returned for evaluation, a definitive root cause could not be determined.

• Brand Name: ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH, 12MM L, 1.8MM OD
• Common Device Name: BIOPSY BRUSH
• 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
• MDR Report Key: 17135778
• Report Number: 3007222345-2023-00027
• Device Sequence Number: 17128906
• Product Code: JAK
• UDI-Device Identifier: 00815686021207
• UDI-Public: 00815686021207
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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: 12/12/2022
• Device Model Number: INS-5300
• Device Catalogue Number: INS-5300
• Device Lot Number: 04239191202
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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