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	10/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a procedure, after the first pass with an endobronchial brush, the sheath of the brush detached from the instrument leaving the wire exposed.The physician was able to successfully complete the intended procedure using another device.There was no procedure delay and there was no harm or injury to the patient as a result of the reported issue.
Additional Manufacturer Narrative
The subject device was returned to veran for evaluation and investigation.It was confirmed that the sheath was completely separated from the housing within the handle.Further investigation of the manufacturing process determined that the device was not meeting the tensile strength specification established by the contract manufacturer.As a result, veran is evaluating the specification surrounding the tensile strength of the sheath to the housing.An evaluation was performed with representatives from medical safety, engineering, quality and regulatory and it was concluded that the malfunction does not present a risk of death or serious injury to the patient.This event is being reported in response to an observation from an external inspection.There has been no associated harm attributed to the reported event.We will continue to monitor and trend similar incidents.
Additional Manufacturer Narrative
This report is being supplemented to correct information provided in previous reports.Correction to the patient identifier in a1 - should be (b)(6).
Additional Manufacturer Narrative
This supplemental report is being submitted to correct the information in a1 and add an investigation conclusion code in h6.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report.After the date of this complaint, it was determined that 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, 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: 16527086
• Report Number: 3007222345-2023-00010
• Device Sequence Number: 12077129
• 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,Followup,Followup
• Report Date (Section B): 09/06/2023

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: 10/19/2023
• Device Model Number: INS-0352
• Device Catalogue Number: INS-0352
• Device Lot Number: 04865210902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 08/15/2023; 08/15/2023; 09/05/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 08/14/2023; 08/15/2023; 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• 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