MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 18GX10CM

Model Number	360-1080-01
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.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 was confirmed.There are stringent computer and photographic inspections that ensure the pincer is not deformed during the manufacturing process.When the device is cocked, the pincer comes out of its window and becomes exposed to the tissues and structures present during the operation.It is also possible that the needle set was inserted into tissue that was too hard for the sensitive pincer, pushing it flat.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.
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
The reporter indicated multiple biopince needles (18ga 10cm) were catching soft tissue between the inner stylet and the outer sample cylinder prior to firing.This resulted in incomplete samples, absent samples, and-in the final case-a renal pseudoaneurysm, the pseudoaneurysm occurred without the needle being fired.Will return all units with this lot number due to multiple occurrences.This report is for the renal pseudoaneurysm.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18GX10CM
• 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: 19641060
• Report Number: 0001625425-2024-01055
• Device Sequence Number: 20619522
• Product Code: KNW
• UDI-Device Identifier: 00886333004379
• UDI-Public: (01)00886333004379(17)280207(10)11461461
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 02/07/2026
• Device Model Number: 360-1080-01
• Device Lot Number: 11461461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2024
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 06/30/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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
• Patient Sex: Unknown