MAUDE Adverse Event Report: Argon Medical Devices, Inc ClosureFast Micro Introducer Sheath Set 7Fr/Ch (2.3mm) x 7cm; Dilator, Vessel for Percutaneous Catheterization

Model Number	MIS-7F07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a vein closure procedure using the micro introducer 7f 7cm 7fx7cm, a floopy part of the wire broke off inside the patient¿s vein and a portion of the sheath was left inside the patient.The event involved the right distal great saphenous vein.Local anesthesia was utilized, and a guidewire was used for insertion.The instructions for use were followed without issue, no resistance was encountered when advancing the device, and no packaging issues were noted.An x-ray was ordered to assess the retained fragment(s).The vein closure procedure was completed and the vein was reported as closed.
Additional Manufacturer Narrative
We conducted a thorough review of the manufacturing and inspection records for this lot and found no deviations or non-conformances.No samples were returned from the customer for review.Additionally, no photographic or visual evidence of any kind was provided, which would have allowed the allegation to be reviewed.Without the affected device, a comprehensive investigation cannot be conducted, and a root cause cannot be determined.As a result, no corrective action is required at this point.However, if samples are returned later, we would be happy to reopen this complaint for re-evaluation.

• Brand Name: ClosureFast Micro Introducer Sheath Set 7Fr/Ch (2.3mm) x 7cm
• 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: 50225567
• Report Number: 0001625425-2026-01002
• Device Sequence Number: 13330438
• Product Code: DRE
• UDI-Device Identifier: 00886333227532
• UDI-Public: (01)00886333227532(17)301203(10)11649222
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K780126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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-7F07
• Device Lot Number: 11649222
• Was Device Available for Evaluation?: No
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown