MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SINGLE-LOOP SNARE RETRIEVAL KIT; DEVICE, PERCUTANEOUS RETRIEVAL

Model Number	380911120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported, "radiopaque tip broke off of the intermediate catheter for the snare.Tip lodge in the heart and was unable to be retrieved.No identified contributing factors.Dr.Denied any use outside of normal practices.Slight curved shape was added to the catheter for direction ability but this is not outside of normal practices.No identified changes in practices.User was properly trained.No noted patient pathologies or conditions that would contribute to tip breaking off.Patient is stable but will require additional monitoring.Per dr., patient will have additional x-ray today, in one week, and in 3 months to monitor foreign object.".
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
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 the manufacturer from the customer.A visual inspection was performed on the returned product.The visual inspection determined that the distal end of the inner sheath did not have the tungsten tips attached, so the complaint in confirmed.A failure investigation was initiated to address the tip detachment issue.The f.I.Will document the root cause identified and the corrective action that was taken to address the issue.Additional information provided in h.3., h.6.And h.11.

• Brand Name: SINGLE-LOOP SNARE RETRIEVAL KIT
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 22107664
• Report Number: 0001625425-2025-01021
• Device Sequence Number: 18180081
• Product Code: MMX
• UDI-Device Identifier: 00886333224609
• UDI-Public: (01)00886333224609(17)280127(10)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K232443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: 380911120
• Device Lot Number: 11607233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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: Other
• Patient Sex: Unknown