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	03/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the sample is available.As of the date of this report, the sample has not been returned.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
It was reported that the introducer was used during vascular access and the guidewire detached in vivo, leaving a fragment in the right proximal great saphenous vein.Access was obtained in the right posterior accessory vein without issue, and the guidewire was advanced easily into the vein without resistance.A 7fr sheath with dilator was advanced over the wire and placed in the vein, and the dilator and guidewire were removed without resistance.Ultrasound imaging then showed foreign material in the vein, and it was identified as part of the guidewire.The provider aborted the planned venaseal procedure and performed a phlebectomy to remove the guidewire fragment.The detached component was successfully removed, and inspection showed the floppy part of the guidewire had separated.The vein was reported to have closed.No further patient injury reported.

• 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 ; 9036759321
• MDR Report Key: 25130926
• Report Number: 0001625425-2026-00961
• Device Sequence Number: 13084612
• Product Code: DRE
• UDI-Device Identifier: 00886333227532
• UDI-Public: (01)00886333227532(17)300730(10)11649413
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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: 11649413
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2025
• 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