MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC ALWAYS-ON TIP TRACKED BRUSH; 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	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Physician experience a brush sheath coming disconnected from the inner portion out of the box.This happened when the brush was down in the scope.Once the brush was extended to push out the fiducial, the sheath became disconnected.A new instrument was opened to complete the procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial report, to provide the details of the investigation, and to correct information provided in the initial report.Correction to g3 of initial report: the date received by manufacturer was 31-jan-2022.The subject device was not returned for analysis.The complaint information indicates that the ins-0352 broke within the sheath while placing a fiducial.According to the investigation, there will be a sheath anchoring and adhesion design change to address this issue.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 BRUSH
• 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: 13656843
• Report Number: 3007222345-2022-00008
• Device Sequence Number: 4984850
• Product Code: JAK
• UDI-Device Identifier: 00815686020538
• UDI-Public: 00815686020538
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 07/16/2024
• Device Model Number: INS-0352
• Device Catalogue Number: INS-0352
• Device Lot Number: 04865210602
• 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: 02/11/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• 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