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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
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
2 subsequent ultrasound guided liver biopsies had biopsy samples taken with needle appropriately positioned, needle gun deployed, but no biopsy sample obtained.Same technique as hundreds of successful prior standard liver biopsies.This creates additional patient risk of bleeding as further biopsy samples are required.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.Three unopened sample was returned from the customer for review.A visual inspection and testing was performed on the ret urned product.Laboratory kidney biopsy testing was performed with the three unused biopince device and it was able to obtain 9 out of 9 samples with no defects.No corrective action can be taken at this time since the issue cannot be duplicated.
Event or Problem Description
2 subsequent ultrasound guided liver biopsies had biopsy samples taken with needle appropriately positioned, needle gun deployed, but no biopsy sample obtained.Same technique as hundreds of successful prior standard liver biopsies.This creates additional patient risk of bleeding as further biopsy samples are required.
Additional Manufacturer Narrative
Udi related data quality updates only corrected information provided in d.4.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 16GA X 10CM
• 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: 18194006
• Report Number: 0001625425-2023-01244
• Device Sequence Number: 7790716
• Product Code: KNW
• UDI-Device Identifier: 00886333224067
• UDI-Public: (01)00886333224067(17)260620(10)11484188
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2026
• Device Model Number: 370-1080-02
• Device Lot Number: 11484188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 11/06/2023; 09/04/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 12/17/2023; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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: Other
• Patient Sex: Unknown