MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION RETRIEVABLE VENA CAVA FILTER (70CM); FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	352506070E
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A doctor was placing an option filter into a patient with some scaring and thicker than average vein calcification.The site was pre dilated with a 6fr sheath and then option was placed over a guidewire without issue.Venogram was performed and option was placed via the pusher without incident.When removing the sheath there was significant resistance and recoiling.The doctor moved closer to the insertion site and attempted to remove the sheath again and the sheath under tension came out but upon examination the tip of the sheath became dislodge and the coil of the sheath was seen at the distal end.Imagining was performed that showed a r/o band in the patient.Attempts were made at a cutdown by attending doctor, but were unable to see or get to the piece of sheath.Patient was sent for a ct scan and the marker band was seen within the venous vessel wall but had not moved.Decision was made to leave the material in the patient and patient was discharged.
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 from the customer for review.Additionally, no photographic or visual evidence of any kind was provided, which would have allowed the allegation to be reviewed.Without necessary evidence, we are unable to perform a thorough investigation or determine a root cause and corrective action currently.As a result, no corrective action is required at this point.However, if samples are returned later, we would be happy to reopen this complaint for re-evaluation.Additional information provided in h.6.And h.11.

• Brand Name: OPTION RETRIEVABLE VENA CAVA FILTER (70CM)
• 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 75758 ; 9036759321
• MDR Report Key: 23857275
• Report Number: 0001625425-2025-01158
• Device Sequence Number: 10389478
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: (01)00886333217151(17)280912(10)11637522
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 352506070E
• Device Lot Number: 11637522
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2025
• 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
• Patient Sex: Unknown