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

Model Number	INS-5300
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Doctor performed an endobronchial tissue biopsy and took 5 tissue samples during the procedure.1 sample was taken with this device during the procedure.
Event or Problem Description
Patient developed a pneumothorax, which required a chest tube and admittance to the hospital after a procedure with the veran spin system and endobronchial instruments.
Event or Problem Description
Additional information regarding the reported event: the procedure was able to be completed.The pneumothorax was identified after the procedure.Multiple veran instruments were utilized during the procedure.This report was submitted for the ins-5300 always-on tip tracked triple needle brush, 12mm l, 1.8mm od.Two other medwatch reports were submitted for instruments involved in the procedure: 3007222345-2022-00023 and 3007222345-2022-00024.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report and to provide the results of the investigation of the reported event.G3 of the initial medwatch report was blank.The date received by manufacturer was 17-oct-2022.As the product was discarded by the facility and the lot number was not provided, there is insufficient information to investigate the failure mode associated with the adverse event.The complaint details indicate that sampling was taking place despite a lack of endobronchial visualization and this caused difficulty for the physician to reach sample locations.Furthermore, multiple veran devices were used during the procedure and it is difficult to assess whether the pneumothorax was caused by any of the veran devices.The associated risk documentation lists a potential cause for pneumothorax is user sampling in anatomical areas that are inappropriate or aggressive in location, and therefore the root cause is mostly associated with user error which may have been caused by complications unrelated to the device.A pneumothorax is a known risk of the device and the procedure.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 TRIPLE NEEDLE BRUSH
• Common Device Name: ENDOBRONCHIAL 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: 15635202
• Report Number: 3007222345-2022-00025
• Device Sequence Number: 20283058
• Product Code: JAK
• UDI-Device Identifier: 00815686021207
• UDI-Public: 00815686021207
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: INS-5300
• Device Catalogue Number: INS-5300
• Was Device Available for Evaluation?: No
• 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: 02/10/2023
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 45 KG