MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE 100CM EUROPE

Model Number	352506100E-E
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be submitted upon investigation completion.
Event or Problem Description
A customer reported that during an ivc filter placement procedure in the patients right brachial vein, the filter had resistance when advancing the cartridge otw and again when using the dilator to push the filter into and through the sheath.When the filter was in the sheath and near the cephalic arch, the filter got stuck and would not advance.All components were removed and the filter had kinked and started to pierce through the side of the deployment sheath.A new kit was used and the filter was placed successfully with some resistance in the same cephalic arch area.It was noticed that there was no pin in the filter/cartridge out of the packaging.There was no patient injury.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded.One sample was returned by the customer for review.The customer returned the pusher wire, cartridge with no filter inside, delivery catheter sheath, and dilator.There was no damage found to any of the returned components.The dilator encountered resistance upon insertion into the sheath and could not advance beyond approximately 16 inches from the proximal.Upon cutting the delivery catheter sheath, it was confirmed that the filter was stuck inside.The complaint is confirmed.The most probable cause for the filter being stuck inside of the sheath is the filter striking the sheath's lining during advancement, damaging the lamination of the sheath.A borescope was used to examine the inner lining of the sheath.Upon examination, there were straight cuts found.A sustaining engineering project has been initiated to investigate the root cause of the delamination issue and to implement a corrective action.Additional information provided in h.3., h.6.And h.11.
Additional Manufacturer Narrative
This supplemental report corrects the date received by manufacturer (g.3.) in the previous supplemental mdr [0001625425-2024-00976] from mar 13, 2025 to mar 17, 2025.

• Brand Name: OPTION ELITE 100CM EUROPE
• Common Device Name: OPTION ELITE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19038363
• Report Number: 0001625425-2024-00976
• Device Sequence Number: 15462803
• Product Code: DTK
• UDI-Device Identifier: 00886333222346
• UDI-Public: 00886333222346
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2025

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: 352506100E-E
• Device Lot Number: 11551974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 03/13/2025; 04/15/2025
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 04/15/2025; 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2023
• 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