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

Model Number	380911330
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter stated "the radiopaque band from the detachment removal kit was inside the patient." the band was retrieved.
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
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 by the customer for evaluation.Additionally, the photographic and videographic evidence provided by the customer appeared to support the reported allegation.The radiopaque band detaching from the retrieval kit may have resulted from a variety of potential factors like excessive mechanical force or insufficient bonding.However, without receiving the sample, we are unable to conduct a comprehensive investigation.As a result, we are unable to determine a definitive root cause or identify an appropriate corrective action at this time.The design team has been notified to ensure they are aware of the issue and can evaluate potential improvements to prevent recurrence.Additional information provided in h.6.And h.11.

• Brand Name: TRIPLE-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: 23293405
• Report Number: 0001625425-2025-01099
• Device Sequence Number: 4786669
• Product Code: MMX
• UDI-Device Identifier: 00886333224616
• UDI-Public: (01)00886333224616(17)270726(10)11584304
• Combination Product (Y/N): N
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 380911330
• Device Lot Number: 11584304
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic