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

Model Number	INS-5600
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient did have a lobectomy on the left lower lobe.Patient was in right lateral decubitus position.Doctor had difficulty registering, but was able to move on.Doctor did attempt a percutaneous approach, but was complaint of poor samples.After the procedure, the patient received a chest x-ray and it was noted to have a pnemothroax.Dr.Places a chest tube and the patient was admitted to the hospital.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report and to correct information provided in the initial report.Correction to b1 and h1 of the initial report: this event was a serious injury, not a device malfunction or product problem.Correction to d1 and d4: the lot number provided by the facility (b)(6) is for an ins-5600, which is a spin perc biopsy needle guide kit.The subject device was not returned for evaluation, as it was discarded by the facility.There was no allegation of device malfunction of any veran devices.A pneumothorax is a known risk of the device and the procedure.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: jennifer andre ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 13419092
• Report Number: 3007222345-2022-00003
• Device Sequence Number: 2455934
• Product Code: JAK
• UDI-Device Identifier: 00815686020736
• UDI-Public: 00815686020736
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2024
• Device Model Number: INS-5600
• Device Catalogue Number: INS-5600
• Device Lot Number: 85599200909
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 93 KG