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

Model Number	INS-5600
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	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
G3: date received by manufacturer should have been 21-jul-2021 in the initial report.The instrument was disposed of by the facility before the pneumothorax was detected.There was no allegation of a malfunction of a veran device.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: 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: christine hardin ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 12351719
• Report Number: 3007222345-2021-00015
• Device Sequence Number: 3939700
• Product Code: JAK
• UDI-Device Identifier: 00815686020736
• UDI-Public: 00815686020736
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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 Expiration Date: 11/16/2024
• Device Model Number: INS-5600
• Device Catalogue Number: INS-5600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 61 KG