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

Model Number	INS-5300
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for evaluation.The issue described in the complaint was confirmed upon investigation when the triple needle brush was slightly extended (<1mm) beyond the end of the sheath.The sheath was measured and found to be within specification.Since the failure mode was not caused by a shortened sheath, a definitive root cause could not be determined.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.
Event or Problem Description
During a navigated thoracic procedure, the physician found that an always-on tip tracked triple needle brush would not retract fully into the sheath out of the package.A new instrument was opened and the case was completed.There was no patient injury or harm associated with the reported event.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was not included in the initial medwatch report.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.
Additional Manufacturer Narrative
This report is being supplemented to correct a1: patient identifier of the previous supplemental report.The correct patient identifier is (b)(6).

• Brand Name: ALWAYS-ON TIP TRACKED TRIPLE NEEDLE 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: 16527023
• Report Number: 3007222345-2023-00011
• Device Sequence Number: 14776728
• Product Code: JAK
• UDI-Device Identifier: 00815686021207
• UDI-Public: 00815686021207
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2023

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: 12/16/2022
• Device Model Number: INS-5300
• Device Catalogue Number: INS-5300
• Device Lot Number: 04239191204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 06/19/2023; 09/26/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 08/14/2023; 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2020
• 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: 76 YR
• Patient Sex: Female