MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY 18GA X 20CM)(INTRODUCER NEEDLE: 17GA X 16.8CM); INSTRUMENT, BIOPSY

Model Number	360-2080-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported "the introducer of the bpu broke off inside the patient when it was being advanced.Ended up having a surgeon remove it.".
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
Following a thorough review of the manufacturing and inspection records for this lot, no deviations or non-conformances were identified.Additionally, an assessment of the returned product was completed, during which it was observed that the coaxial introducer cannula was broken in two pieces.Under magnified inspection, it was observed that the cannula showed signs of bending and tearing.It is possible that an event occurred in the user environment that led to the bending and breaking of the introducer cannula.The devices are closely monitored for defects both during manufacturing and packaging.Since a manufacturing defect could not be identified, no corrective action was taken at this time.Argon will continue to monitor for recurrence.Additional information provided in d.9., h.3., h.6 and h.10.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY 18GA X 20CM)(INTRODUCER NEEDLE: 17GA X 16.8CM)
• 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: 22211685
• Report Number: 0001625425-2025-01032
• Device Sequence Number: 8132620
• Product Code: KNW
• UDI-Device Identifier: 00886333224050
• UDI-Public: (01)00886333224050(17)290622(10)11578392
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: 360-2080-03
• Device Lot Number: 11578392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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