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

Model Number	382007030
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
A customer reported the device was used at stent-grafting procedure addressing abdominal aortic aneurysm.Inserted the delivery catheter through the left femoral artery with over-the-wire technic to catch the contralateral afx i imb wire on the right side.After removing the guidewire when the delivery catheter reached the terminal and advanced the snare.Attempted to catch the afx wire by the snare loops, however, the wire could not be caught successfully.Then to change the location of the catching, the snare was advanced further, but because common iliac artery was highly tortuous, making it difficult for the device to advance.During this manipulation, the marker band on the delivery catheter came off and it remained at the distal end of the left internal iliac artery (likely the superior gluteal artery).It was determined that retrieving the marker was not possible, so the procedure continued as planned by exchanging the device and the guidewire with another new one.
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.One used sample was returned to argon from the customer.A visual inspection was performed on the returned product.A visual inspection of the returned device confirmed that the radiopaque band was absent from the delivery catheter sheath.There was a cylindrical indentation found on the distal end of tubing of delivery catheter which indicates that the marker band was swaged onto the tubing at some point.This component is supplied to argon by an external supplier.Scar-00224 will be updated to include the affected component part number and lot number and will be forwarded to the supplier for further investigation.Hhe-1392 will also be updated to document the product details for this failure.Additional information provided in d.9., h.3., h.6., and h.11.

• Brand Name: ATRIEVE VASCULAR SNARE KIT 7FR
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75758
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75758 ; 9036759321
• MDR Report Key: 23950061
• Report Number: 0001625425-2026-00918
• Device Sequence Number: 10648944
• Product Code: MMX
• UDI-Device Identifier: 20886333003994
• UDI-Public: (01)20886333003994(17)291001(10)11592423
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 04/28/2026

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: 382007030
• Device Lot Number: 11592423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown