MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT (BIOPSY INSTRUMENT: 18GA X 10CM); INSTRUMENT, BIOPSY

Model Number	360-1080-03
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Biopince with 15 cm length was packed in packaging marked 10 cm length.Device was used on patient with co-axial needle ct guided.Upon use the biopince penetrated 5 cm longer than anticipated and planned resulting in bleeding and tissue damage.Customer has so far not shared the extent of patient impact.Customer identified three more biopince where length of device did not match what was marked on the packaging.These were not used.
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-conformance's were found.There were no physical samples provided, however images were provided.Based on the images provided and multiple previous complaints associated with this lot number for the same issue, the complaint is confirmed.The most likely cause of this issue was due to an operator error while the parts were being pulled for packaging.A capa has been opened to investigate the issue in detail.Additionally, an hhe was performed to assess the risks associated with this issue.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT (BIOPSY INSTRUMENT: 18GA X 10CM)
• 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: 21531818
• Report Number: 0001625425-2025-00967
• Device Sequence Number: 7133607
• Product Code: KNW
• UDI-Device Identifier: 00886333224012
• UDI-Public: (01)00886333224012(17)270619(10)11575114
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: 360-1080-03
• Device Lot Number: 11575114
• Was Device Available for Evaluation?: No
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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: Other
• Patient Sex: Unknown