MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT 16GA X 9CM; INSTRUMENT, BIOPSY

Model Number	701116090
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the sample is available.As of the date of this report, the sample has not been returned.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
When using a biopsy needle to perform breast puncture on a patient's breast mass, it is difficult to puncture the needle.It was found that the needle has a bent groove, which poses a risk of damaging the surrounding tissue of the mass.It is necessary to remove the biopsy needle again, straighten the valve, and re puncture, which may cause the mass tissue to overflow during puncture.
Additional Manufacturer Narrative
We conducted a thorough review of the manufacturing and inspection records for this lot and found no deviations or non-conformances.Unfortunately, we did not receive any samples for evaluation, nor did we receive any photographic or visual evidence that would have allowed us to review the allegation in detail.Without this necessary evidence, we are unable to perform a thorough investigation or determine a root cause and corrective action at this time.As a result, no corrective action is required at this point.However, if samples are returned at a later date, we would be happy to reopen this complaint for re-evaluation.Additional information provided in h6 and h11.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT 16GA X 9CM
• Common Device Name: INSTRUMENT, BIOPSY
• 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: 21945313
• Report Number: 0001625425-2025-01000
• Device Sequence Number: 18276450
• Product Code: KNW
• UDI-Device Identifier: 00886333005918
• UDI-Public: (01)00886333005918(17)290328(10)11564327
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 701116090
• Device Lot Number: 11564327
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian