MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	352506070E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician deployed the filter over the wire (otw) via the femoral access.The filter was successfully deployed; however, the most distal ro band on the dilator came off the dilator and ended up in the patient's ivc.The flouoro images will be provided, but hospital risk team will keep device.
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 evidence provided by the customer appeared to support the reported allegation.The ro band detachment off the dilator may have resulted from a variety of potential factors like insufficient bonding or excessive mechanical force.However, without receiving the sample, we are unable to conduct a comprehensive investigation.As a result, we cannot determine a definitive root cause or establish an appropriate corrective action at this time.The design team and the production supervisor have been notified of the issue to ensure they are aware and to evaluate measures to prevent recurrence.Additional information provided in h.3., h.6.And h.11.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• 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: 23359118
• Report Number: 0001625425-2025-01105
• Device Sequence Number: 8965040
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: (01)00886333217151(17)280821(10)11634899
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 352506070E
• Device Lot Number: 11634899
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2025
• 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