MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 18GX10CM; INSTRUMENT, BIOPSY

Model Number	360-1080-01
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Codes	Dyspnea (1816); Pneumothorax (2012)
Date of Event	04/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported "on (b)(6) 2025, during percutaneous lung puncture, there was no response to the disposable biopsy needle shrapnel.One needle was immediately replaced, resulting in prolonged operation time and symptoms of shortness of breath and suffocation in the patient.Ct showed pneumothorax.Immediate closed chest drainage was performed, and the patient's symptoms were relieved.".
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Additional Manufacturer Narrative
We have carefully reviewed the manufacturing and inspection records for this lot and found no deviations or non-conformances.Everything meets our high standards of quality.Despite multiple requests, we have not yet received the sample related to the complaint.Additionally, no photographic or visual evidence has been provided to support a review of the concern.Without this necessary information, a thorough investigation cannot be conducted, and identifying a root cause or corrective action is not feasible.At this time, no corrective action is required.However, if the samples are provided at a later date, we would be happy to reopen the complaint for further evaluation.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18GX10CM
• Common Device Name: INSTRUMENT, BIOPSY
• 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: 22384424
• Report Number: 0001625425-2025-01050
• Device Sequence Number: 12927519
• Product Code: KNW
• UDI-Device Identifier: 00886333004379
• UDI-Public: (01)00886333004379(17)270726(10)11582492
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K904987
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 360-1080-01
• Device Lot Number: 11582492
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian