MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ULTRACORE BIOPSY NEEDLE 18GA X 16CM

Model Number	762618160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
The customer reported "the patient is experiencing bleeding and pneumothorax.".
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.The customer did not return any samples for evaluation.Additionally, no photographic or visual evidence was submitted that would have allowed this allegation to be reviewed.Without the necessary evidence, a thorough investigation cannot be performed.Determining a root cause and corrective action is not possible.No corrective action is required at this point.If the samples are returned at a later date, then this complaint may be reopened for re-evaluation.Additional information provided in h.6.And h.11.

• Brand Name: ULTRACORE BIOPSY NEEDLE 18GA X 16CM
• Common Device Name: ULTRACORE
• 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: 20913907
• Report Number: 0001625425-2024-01170
• Device Sequence Number: 8600237
• Product Code: DWO
• UDI-Device Identifier: 00886333006427
• UDI-Public: (01)00886333006427(17)280814(10)11490967
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K921418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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 Expiration Date: 08/14/2024
• Device Model Number: 762618160
• Device Lot Number: 11490967
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2023
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian