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	05/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The physician reported that after the ins-0352 (always-on tip tracked brush, 15mm l, 1.8mm od) was deployed one time, the outer clear sheath detached from the black handle portion when the brush was retracted.The brush was removed from the patient and when the technician deployed the brush to extract the sample, the brush could not deploy out.The physician was able to successfully complete the intended procedure using a new instrument.There was no procedural delay.There was no injury to the patient or user as a result of the reported issue.This report is being submitted for the sheath detaching from the black handle.
Additional Manufacturer Narrative
The device was not returned to veran for evaluation.However, a photo was provided.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.
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: the subject instrument 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.

• 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: 17210680
• Report Number: 3007222345-2023-00036
• Device Sequence Number: 14812784
• Product Code: JAK
• UDI-Device Identifier: 00815686020538
• UDI-Public: 00815686020538
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/10/2023

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: 05/14/2024
• Device Model Number: INS-0352
• Device Catalogue Number: INS-0352
• Device Lot Number: 04865210511
• 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: 05/12/2022
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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