MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ARTERIAL LINE KIT/1 20GA X 6"; CATHETER KIT

Model Number	498100
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During insertion of brachial arterial line, the wire would not feed past the hub.Unsure if blockage at hub or the wire too big to pass through hub.I used a small wire to navigate the blockage, and then using a cannula over the small wire, was then able to insert the line.This approach was used based on previous scenarios.It is not a desirable or elegant solution.
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.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.One opened sample was returned for review.The customer returned only a guidewire and did not return the catheter for evaluation.The wire was measured and found to be within specification according to dwg-35-2803-xx, rev.B.Without the catheter to evaluate, the results of the investigation for this complaint are inconclusive.A definite root cause for the reported issue could not be determined since all the speculated components were not returned to complete a thorough investigation.Since the investigation results of this complaint are inconclusive, no corrective action is possible.At this time, there have been no other complaints regarding this issue with this part number or lot number, however, we will continue to monitor for issues of this nature in the future.Additional information provided in h.6.And h.11.

• Brand Name: ARTERIAL LINE KIT/1 20GA X 6"
• Common Device Name: CATHETER KIT
• 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: 21473890
• Report Number: 0001625425-2025-00956
• Device Sequence Number: 3391030
• Product Code: GDY
• UDI-Device Identifier: 00886333215539
• UDI-Public: (01)00886333215539(17)280531(10)11565941
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K780871
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: 498100
• Device Lot Number: 11565941
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• 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: Required Intervention
• Patient Sex: Unknown