MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE

Model Number	360-1080-03
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
(b)(6) stated the device did not collect adequate samples and caused temporary patient bleed that was resolved.A co-ax was used in the case.
Additional Manufacturer Narrative
A review of the dhrs of the top level and sublots as well as the inspection records was conducted, and no deviations or non-conformances were found relating to this issue.One opened sample was returned from the customer for review.A visual inspection was performed on the returned product, and it was found that the pincer was flattened, inhibiting it from properly obtaining a sample.The complaint is confirmed.There are stringent computer and photographic inspections that ensure the pincer is not deformed during the manufacturing process and has the proper radius.When the device is cocked, the pincer comes out of its window and becomes exposed to the tissues and structures present during the operation.Without the use of a proper sized coaxial needle, such as the inner diameter being too small, the pincer can be pushed flat.It is also possible that the needle set was inserted into tissue that was too hard for the sensitive pincer, pushing it flat.Additionally, the exact conditions of the biopsy performed in the user environment is not known.If the device is fired into either very fatty or some sort of calcified tissue, then it is possible for the needle set components to bend out of shape and the pincer to have a failure when collecting a sample and resulting in an incomplete or no sample defect.Since the most likely cause for the damaged needles is related to an event within the user's environment and not a manufacturing issue, no corrective action can be implemented at this time.
Event or Problem Description
(b)(6) stated the device did not collect adequate samples and caused temporary patient bleed that was resolved.A co-ax was used in the case.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE
• Common Device Name: BIOPINCE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 16761490
• Report Number: 0001625425-2023-01028
• Device Sequence Number: 6034323
• Product Code: KNW
• UDI-Device Identifier: 00886333224012
• UDI-Public: 00886333224012
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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 Expiration Date: 03/01/2026
• Device Model Number: 360-1080-03
• Device Catalogue Number: 360-1080-03
• Device Lot Number: 11466568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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; Other
• Patient Sex: Unknown