MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN PERC NEEDLE; PERCUTANEOUS BIOPSY NEEDLE

Model Number	INS-5600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pneumothorax (2012); Tachycardia (2095); Respiratory Arrest (4461)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Date of procedure: (b)(6) 2021.Date or report: 18-may-2021.Physician attempted a navigational bronchoscopy but was unsuccessful in reaching the target.The patient was transitioned into a left lateral decubitus position and proceeded with registration, however both the main and left secondary carina were lining up.A lumen refinement was conducted.Once both the main and left secondary carina were check and both were aligned correctly, the perc procedure began.The physician obtained the first biopsy using the biopsy gun with a 2cm throw.(b)(6) was present in the room and confirmed that the first sample taken was benign.Dr.(b)(6) went back and continued to take biopsies with both the biopsy gun and fna needle, but was unsuccessful obtaining any tissue.After 4 failed attempts, the veran medical representative in the room called into vsupport.Vsupport checked the registration, along with the entry point and trajectory of perc needle.The needle was never removed from the patient.Vsupport confirmed the needle was in the nodule.As the physician completed the procedure, an ultrasound technician was called into the room to check for pneumothorax and it appeared negative.A chest ct was conducted after the ultrasound and confirmed that the patient did have pneumothorax.A chest tube was being placed when the patient started to experience a rapid heartrate.The patient stopped breathing and a code blue call was called.The patient was hospitalized and later was released.
Additional Manufacturer Narrative
This report is being supplemented to correct information provided in the initial medwatch report, and to provide additional information that was inadvertently not included in the initial report.Correction to a3 of initial report: patient was a male.Correction to b4 of initial report: date of this report was 17-jun-2021.Correction to g3 of initial report: date received by manufacturer was 14-may-2021.A2: patient was reportedly in his 70's, but an exact age was not provided.The hospital discarded the instruments after the procedure so no instruments were returned for investigation.There was no allegation of 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 NEEDLE
• Common Device Name: PERCUTANEOUS 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: 12022252
• Report Number: 3007222345-2021-00011
• Device Sequence Number: 4899198
• Product Code: JAK
• UDI-Device Identifier: 00815686020736
• UDI-Public: 00815686020736
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Other
• 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
• Device Lot Number: 86238210114
• 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: 06/18/2021
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• 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: Hospitalization
• Patient Sex: Male