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

Model Number	INS-0352
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The sheath separated at the handle (next to the black handle).When the rt tried to place a fiducial marker, the brush was no longer able to "throw" and therefore could not place the fiducial.Procedure was completed.
Event or Problem Description
Correction to typing errors in b5 of the initial report: the sheath separated at the handle (next to the black handle).There was reportedly a two-minute delay to switch out the instruments.There was no patient or procedure impact due to the reported issue.The issue occurred with two brushes consecutively.The medwatch for the second brush was reported under medwatch 3007222345-2022-00005.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information regarding the event, the device evaluation, and information that was inadvertently not provided in the initial medwatch report.G3 was blank on the initial report and should have been jan.12, 2022.The device history record was reviewed and no issues were identified that could have caused or contributed to the reported issue.The instrument was returned and it was confirmed that the sheath had come detached from the handle.Based on the results of 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: 13509849
• Report Number: 3007222345-2022-00004
• Device Sequence Number: 12390753
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: 07/16/2024
• Device Model Number: INS-0352
• Device Catalogue Number: INS-0352
• Device Lot Number: 04865210602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Weight: 73 KG