MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CO-AXIAL INTRODUCER NEEDLE 17GA X 11.8CM

Model Number	MCXS1815BP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient underwent a puncture biopsy of the left lung mass.After the surgery, the patient's vital signs were stable and they felt a slight suffocation.The next day, a chest x-ray was reviewed to report left pneumothorax, and the patient and their family members were communicated about the condition.If the patient experienced complications after the puncture surgery, a closed thoracic drainage surgery was performed, and the patient's suffocation symptoms were relieved after the surgery.
Additional Manufacturer Narrative
According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: CO-AXIAL INTRODUCER NEEDLE 17GA X 11.8CM
• Common Device Name: CO-AXIAL INTRODUCER NEEDLE
• 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: 18253172
• Report Number: 0001625425-2023-01248
• Device Sequence Number: 17919284
• Product Code: KNW
• UDI-Device Identifier: 00886333002405
• UDI-Public: (01)00886333002405(17)271202(10)11451919
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K980004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2024

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 Model Number: MCXS1815BP
• Device Lot Number: 11451919
• Was Device Available for Evaluation?: No
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 09/01/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown