MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC ALWAYS-ON TIP TRACKED BRUSH

Model Number	INS-0352
Medical Device Problem Codes	Material Separation (1562); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Staff opened a endobronchial bipsy brush and the protective sheath fell off before it was used on the patient.A second brush was opened and the procedure proceeded.
Event or Problem Description
Additional information regarding the reported event: there was no impact on the patient or the procedure.The procedure was completed after a 1-minute delay to switch to a new instrument.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report and to correct information provided in the initial report (correction to a2).Although a return authorization was issued to the facility for the return of the instrument, the device was not returned for evaluation.Based on the details of the reported issue, after the date of this event, it was determined 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: 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: 12964234
• Report Number: 3007222345-2021-00022
• Device Sequence Number: 4389464
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: 07/14/2024
• Device Model Number: INS-0352
• Device Catalogue Number: INS-0352
• Device Lot Number: 04865210518
• 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: 11/08/2021
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2021
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 72 KG