MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE; BIOPSY NEEDLE

Model Number	INS-5410
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	11/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During a tissue sampling procedure, a 22ga needle was used inside a spin access catheter (90 degree).A coil break of the 22ga needle occurred while using the needle inside the spin access catheter.No samples were taken before the coil break.A 2-minute delay of the procedure was reported.The forceps were used to obtain samples.After the procedure, the patient had a small pneumothorax.As a precaution, the clinician placed a chest tube.The clinician could not determine whether or not it was associated with the 22 ga needle.The needle may have been extended for a short period of time during the procedure, however it was not used to obtain tissue samples. .
Additional Manufacturer Narrative
There were three devices (ins-5410, ins-5910, and endobronchial forceps (model number unknown)) associated with the same reported event.Device relationship to the event could not be determined, as a result, a total of three (3) medical device reports associated with the same event are submitted.This report is one (1) of three (3) total reports (reference 300722345-2023-00006 and 3007222345-2023-00007).
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 medwatch report.Correction to b4 of the initial medwatch report: date of this report was 17-feb-2023.Based on the results of the investigation, it is unlikely that use of the ins-5410 22ga needle (subject device) resulted in the pneumothorax because the complaint information received indicates that no samples were taken with the needle.The needle portion of the ins-5410 is covered by a plastic sheath, so if the needle was not used to sample, then it is unlikely to have perforated the airway wall to have resulted in a pneumothorax.A pneumothorax is a known risk of the device and the procedure.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: ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE
• 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: 16396725
• Report Number: 3007222345-2023-00005
• Device Sequence Number: 12148462
• Product Code: JAK
• UDI-Device Identifier: 00815686020637
• UDI-Public: 00815686020637
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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 Expiration Date: 10/01/2023
• Device Model Number: INS-5410
• Device Catalogue Number: INS-5410
• Device Lot Number: 03779190213
• 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: 11/04/2021
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 79 KG