MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ULTRACORE BIOPSY NEEDLE 18GA X 16CM

Model Number	762618160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent ct guided biopsy of a space occupying lesion in the upper lobe of the right lung in the ct room of the radiotherapy department.A total of 3 gray red and gray black tissues were obtained, some of which were fragmented and had a size of approximately 0.5-1.0 × 0.1cm.The specimens were fixed in 10% formalin solution and sent to the pathology department for cytological examination.The coaxial puncture needle was removed and the puncture site was wrapped and fixed.Ct re examination showed no exudation in the puncture site, moderate pneumothorax on the right side, and no pleural effusion.
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.The customer did not return any samples for evaluation.Additionally, no photographic or visual evidence was submitted that would have allowed this allegation to be reviewed.Without the necessary evidence, a thorough investigation cannot be performed.Determining a root cause and corrective action is not possible.No corrective action is required at this point.If the samples are returned at a later date, then this complaint may be reopened for re-evaluation.Additional information provided in h.6.And h.11.

• Brand Name: ULTRACORE BIOPSY NEEDLE 18GA X 16CM
• Common Device Name: ULTRACORE BIOPSY NEEDLE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 4258996692
• MDR Report Key: 20550093
• Report Number: 0001625425-2024-01126
• Device Sequence Number: 21073163
• Product Code: DWO
• UDI-Device Identifier: 00886333006427
• UDI-Public: (01)00886333006427(17)280622(10)11482269
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K921418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 762618160
• Device Lot Number: 11482269
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2023
• 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 Sex: Unknown