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	09/14/2024
Type of Reportable Event	Serious Injury
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.If the samples are returned at a later date, then this complaint may be reopened for re-evaluation.
Event or Problem Description
On (b)(6) 2024, the patient underwent percutaneous lung biopsy 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 x-ray ct scan was performed, and the ct image showed no significant changes in pneumothorax.After the surgery, the patient returned to the ward safely.The hospital reported this case to nmpa.

• 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: 20915713
• Report Number: 0001625425-2024-01171
• Device Sequence Number: 8466120
• Product Code: DWO
• UDI-Device Identifier: 00886333006427
• UDI-Public: (01)00886333006427(17)280622(10)11482269
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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 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: 11/12/2024
• Initial Report FDA Received Date: 12/12/2024
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian