MAUDE Adverse Event Report: ARGON MEDICAL DEVICES TRU-CORE II BIOPSY INSTRUMENT 14GA X 10CM

Model Number	763114100X
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Codes	Hematoma (1884); Needle Stick/Puncture (2462)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Trucore 14g and 16g used for mammae biopsy.No co-axial needle used.Complaint that they don`t get a full 19mm sample.Therefore, they had to repeat the procedure several times and it resulted in a hematoma.They have the impression that the needle isn`t sharp because it fastened to the parenchyma and they had to use extra force to get it out.
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
Trucore 14g and 16g used for mammae biopsy.No co-axial needle used.Complaint that they don`t get a full 19mm sample.Therefore, they had to repeat the procedure several times and it resulted in a hematoma.They have the impression that the needle isn`t sharp because it fastened to the parenchyma and they had to use extra force to get it out.
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.Nineteen unopened devices were returned for evaluation.The actual used device was not returned.Visual inspection found no damage to the devices.Five devices were opened and test fired with no issues encountered.The devices were also checked for sharpness and were found to be within argon specification.It was stated that the customer chose not to utilize a corresponding coaxial, which have aided with the use of the device.It was not stated whether or not the device was test fired, which could cause issues with the functionality of the device, per the ifu.Since no manufacturing defects could be found with the returned devices, no corrective action was taken.

• Brand Name: TRU-CORE II BIOPSY INSTRUMENT 14GA X 10CM
• Common Device Name: TRU-CORE
• 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: 16304942
• Report Number: 0001625425-2023-00962
• Device Sequence Number: 6767473
• Product Code: KNW
• UDI-Device Identifier: 00886333006649
• UDI-Public: 00886333006649
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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: 763114100X
• Device Catalogue Number: 763114100X
• Device Lot Number: 11430854
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown