MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT; INSTRUMENT, BIOPSY

Model Number	360-1080-03
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An elderly male with no significant past medical history.Underwent outpatient procedure for left kidney biopsy due to proteinuria.Using ct guidance, a 17-gauge coaxial needle was directed into lower pole of the left kidney.The 18-gauge biopsy needle was inserted coaxially, and 4 core biopsy specimens were obtained.The biopsy gun was malfunctioning, with no core obtained despite firing and causing a small hematoma.The coaxial needle was then removed after injection of gelfoam slurry and hemostasis was achieved with manual compression.Sterile dressings were applied.Post biopsy limited ct scan showed no evidence of hematoma or other complication.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 16544933
• Report Number: 16544933
• Device Sequence Number: 6007332
• Product Code: KNW
• UDI-Device Identifier: 00886333224012
• UDI-Public: (01)00886333224012(17)260104(10)11456554
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2023
• Report Date (Section F): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 360-1080-03
• Device Catalogue Number: 360-1080-03
• Device Lot Number: 11456554
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 03/06/2023