MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 16GA X 10CM

Model Number	370-1080-02
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
Reporter indicated "bedside portable for liver biopsy on (b)(6) 2024 with dr.(b)(6).2 passes were taken with biopince biopsy 16ga x 10cm needle: the passes failed at 0921 & 0922.Unfortunately, the doctor had to use another biopsy device to complete the procedure, which entailed 2 more passes.The patient was in extreme pain post procedure." immediate actions taken: the doctor replaced the failing with a device with another device.Informed supervisor of the department of what transpired.Additionally, the patient was hypotensive, patient had an angio/cta performed by the on call team.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.Eighteen samples were returned from the customer for review.A visual inspection was performed on the returned product, and it was found that the pincers were flattened, inhibiting them from properly obtaining a sample.The complaint was confirmed.There are stringent computer and photographic inspections that ensure the pincer is not deformed during the manufacturing process and has the proper radius.Optimization actions are be performed to produce better quality devices and mitigate this issue.Argon will continue to monitor for recurrence.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 16GA X 10CM
• Common Device Name: BIOPINCE
• 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: 19635868
• Report Number: 0001625425-2024-01052
• Device Sequence Number: 15303738
• Product Code: KNW
• UDI-Device Identifier: 00886333224005
• UDI-Public: (01)00886333224005(17)270408(10)11566037
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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: 370-1080-02
• Device Lot Number: 11566037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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