MAUDE Adverse Event Report: Argon Medical Devices, Inc 6F Micro Introducer Set 7CM VNUS; Dilator, Vessel for Percutaneous Catheterization

Model Number	MIS-6F07
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during treatment of a distal segment of the great saphenous vein (gsv) using the micro introducer, 6f 7cm, the tip of the introducer wire detached and a portion of the wire measuring about 3 cm was believed to remain in the patient.The device fragment was not retrieved, and the physician reportedly did not recognize the issue until after the procedure.One segment was treated and vein closure was achieved.The lumen was flushed prior to use.It was unknown if there was any patient involvement or complications as a result of the event.
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.

• Brand Name: 6F Micro Introducer Set 7CM VNUS
• Common Device Name: Dilator, Vessel for Percutaneous Catheterization
• Manufacturer (Section D): Argon Medical Devices, Inc; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; +1(903)675-9321
• MDR Report Key: 50107374
• Report Number: 0001625425-2026-00999
• Device Sequence Number: 18661219
• Product Code: DRE
• UDI-Device Identifier: 00886333226917
• UDI-Public: 00886333226917
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K780126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2026

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: MIS-6F07
• 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: 07/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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