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 Codes	Hemoptysis (1887); Pneumothorax (2012)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated "the patient underwent ct guided right lung biopsy surgery, and 3 biopsies were taken.The patient developed hemoptysis, and ct re examination showed significant pneumothorax.".
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.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.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.

• Brand Name: CO-AXIAL INTRODUCER NEEDLE 17GA X 11.8CM
• Common Device Name: CO-AXIAL INTRODUCER
• 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: 20241166
• Report Number: 0001625425-2024-01106
• Device Sequence Number: 18165118
• Product Code: KNW
• UDI-Device Identifier: 00886333002405
• UDI-Public: (01)00886333002405(17)280620(10)11484165
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: MCXS1815BP
• Device Lot Number: 11484165
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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