MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. ALWAYS-ON TIP TRACKED BRUSH, 15MM L, 1.8MM OD; BIOPSY BRUSH

Model Number	INS-0352
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The physician stated during the first pass with the brush (ins-0352 always-on tip tracked brush, 15mm l, 1.8mm od), the brush was broken at the most distal part of the black piece.The staff mentioned it seemed the sheath was sliding within the black handle, so when the doctor would "brush out", it was still inside the sheath.The physician decided to cut the brush to send to pathology.There was an approximate 10-minute procedure delay; however, there was no harm or injury to the patient as a result of the reported issue.
Additional Manufacturer Narrative
The subject device was returned to veran for evaluation and investigation.It was confirmed that the most proximal end of the sheath became unattached from the handle.Since the date of this event, the manufacturing process is being updated to address this failure mode.Veran will continue to monitor field performance for this device.This event is being reported 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 BRUSH, 15MM 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 ; 3146598500
• MDR Report Key: 17230431
• Report Number: 3007222345-2023-00045
• Device Sequence Number: 7063843
• Product Code: JAK
• UDI-Device Identifier: 00815686020538
• UDI-Public: 00815686020538
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 06/29/2023

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: 08/18/2024
• Device Model Number: INS-0352
• Device Catalogue Number: INS-0352
• Device Lot Number: 04865210707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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