MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC ATRIEVE VASCULAR SNARE KIT 7FR; DEVICE, PERCUTANEOUS RETRIEVAL

Model Number	382007045
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
When moving the catheter up and down to catch the wire of afx device, the marker band was detached.It was found that the marker band was inside 8 fr long sheath and then the sheath was removed and the marker was taken out of the body.The kit was exchanged with a new one and the procedure was completed.
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A final report will be submitted upon investigation completion.

• Brand Name: ATRIEVE VASCULAR SNARE KIT 7FR
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• 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: 24479646
• Report Number: 0001625425-2026-00944
• Device Sequence Number: 10300826
• Product Code: MMX
• UDI-Device Identifier: 20886333004014
• UDI-Public: (01)20886333004014(17290711(10)11581439
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021606
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2026

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: 382007045
• Device Lot Number: 11581439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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
• Patient Sex: Unknown