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

Model Number	762618160
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Percutaneous lung biopsy was performed in the ct room of the radiotherapy department.Postoperative ct images showed that the patient developed a small amount of pneumothorax.Five minutes later, a chest ct scan was performed, and the ct images showed no significant changes in pneumothorax.After the surgery, the patient returned to the ward safely.The sample could not be taken out.
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.Corrected information provided in h.6.And h.11.

• Brand Name: ULTRACORE BIOPSY NEEDLE 18GA X 16CM
• Common Device Name: ULTRACORE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 20397378
• Report Number: 0001625425-2024-01116
• Device Sequence Number: 3579529
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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 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: 09/09/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/03/2025
• 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