MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH, 12MM L, 1.8MM OD; BIOPSY BRUSH

Model Number	INS-5300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with a history of chronic obstructive pulmonary disease (copd) was having a biopsy performed on a large target in the left upper lobe of the lung.After the procedure, the patient was scanned and a pneumothorax was noted.A chest tube was placed and the patient was sent home on (b)(6) 2021.The patient returned the next day to have the chest tube removed.The patient recovered and was discharged.The biopsy samples indicate the patient had adenocarcinoma.The doctor used ins-5410, flex needle, and ins-5300, triple needle brush, to take the biopsy sample.One medwatch report was previously submitted for this event on medwatch 3007222345-2021-00016 for the ins-5410 always-on tip tracked 22ga anso flexible needle, 15mm l, 1.8mm od.On further review, it was later determined that a separate medwatch report should have been submitted for the ins-5300 always-on tip tracked triple needle brush, 12mm l, 1.8mm od.This medwatch report is being submitted for the ins-5300.
Additional Manufacturer Narrative
The subject device was not returned for evaluation and the lot information was not provided.There was no allegation of device malfunction of any veran device.A root cause could not be determined.A pneumothorax is a known risk of the device and the procedure.This 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, 12MM 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: 17552741
• Report Number: 3007222345-2023-00078
• Device Sequence Number: 6683978
• Product Code: JAK
• UDI-Device Identifier: 00815686021207
• UDI-Public: 00815686021207
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 08/15/2023

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male