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	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject devices were not returned to veran for evaluation.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.
Event or Problem Description
The physician reported that while trying to place a fiducial marker, the first brush (ins-0352 always-on tip tracked brush, 15mm l, 1.8mm od) broke when the sheath separated from the hub of the handle.The physician was able to place 2 fiducial markers with a second brush before the sheath separated from the hub of the handle.A third brush was opened, but the physician was unable to place a fiducial marker before the sheath came apart from the hub of the handle.They confirmed fiducial marker placement using fluoroscopy.The physician was able to successfully complete the intended procedure.There was no procedure delay and there was no injury to a patient or user as a result of the reported issues.This report is being submitted for the issue with the second ins-0352.The issue with the first ins-0352 is being reported on medwatch 3007222345-2023-00042.The issue with the third ins-0352 is being reported on medwatch 3007222345-2023-00044.
Additional Manufacturer Narrative
This report is being supplemented to correct information provided in the initial medwatch report and to provide information that was inadvertently not included in the initial medwatch report.Corrections to d9 and h3: one of the two instruments from lot 04865210707 was returned for evaluation after this complaint was closed.The investigation confirmed that the sheath had come detached from the handle.A failure investigation was performed for this failure mode.As a result, there was a planned sheath anchoring and adhesion design change to address this issue.Note that lot 04865210707 was the subject of two mdrs for this event (3007222345-2023-00042 and 3007222345-2023-00043).

• 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: 17226427
• Report Number: 3007222345-2023-00043
• Device Sequence Number: 15255632
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2021
• 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 Sex: Unknown