MAUDE Adverse Event Report: ARGON MEDICAL DEVICES 1S ONESTIC MICRO-ACCESS INTRODUCER 8F; DILATOR, VESSEL FOR PERCUTANEOUS CATHETERIZATION

Model Number	497862
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
A reporter indicated "twice now, the same provider has experienced an item break in two as he pulled the introducer back out of the vessel.Nothing left in the patient.No harm to the patient, but they were both out of the same box.We¿ve pulled all of the remaining items in that box (with that lot number) from circulation." they are available for return.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded relating to this issue.Two sealed and two unsealed samples were returned to argon from the customer.A visual inspection was performed on the returned product.The visual inspection determined that the dilator hubs were detached from the tubing.This is likely due to the tubing not being pushed all the way onto the core pin during the over molding process.Since the number of confirmed complaints with this issue is currently within the predicted occurrence, no further actions will be taken at this time.However, argon will continue to monitor for recurrence.Additional information provided in h.3., h.6.And h.11.

• Brand Name: 1S ONESTIC MICRO-ACCESS INTRODUCER 8F
• Common Device Name: DILATOR, VESSEL FOR PERCUTANEOUS CATHETERIZATION
• 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: 22986500
• Report Number: 0001625425-2025-01075
• Device Sequence Number: 9548966
• Product Code: DRE
• UDI-Device Identifier: 00886333223794
• UDI-Public: (01)00886333223794(17)300623(10)11627341
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K780126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: 497862
• Device Lot Number: 11627341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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
• Patient Sex: Unknown