MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN PERC BIOPSY NEEDLE GUIDE KIT

Model Number	INS-5600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
An endobronchial biopsy procedure was performed with forceps before moving onto the percutaneous procedure.During the second registration, both the min and secondary carinas were accurate.During the post op ct scan, it was found that the patient had a partial pneumothorax.No chest tube was placed.The patient went home on the same day.The patient returned to the hospital the next day and an xray confirmed that the pneumothorax had resolved on its own.
Additional Manufacturer Narrative
This report is being supplemented to notify the fda that this submission (medwatch 3007222345-2022-00007) was a duplicate submission of the event described in medwatch 3007222345-2021-00015.

• Brand Name: SPIN PERC BIOPSY NEEDLE GUIDE KIT
• Common Device Name: BIOPSY NEEDLE
• 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: 13518953
• Report Number: 3007222345-2022-00007
• Device Sequence Number: 5248435
• Product Code: JAK
• UDI-Device Identifier: 00815686020736
• UDI-Public: 00815686020736
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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
• Device Model Number: INS-5600
• Device Catalogue Number: INS-5600
• 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: 10/10/2023
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 10/11/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 61 KG