MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER

Model Number	352506100E
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
The customer said that the option filter would not deploy.They said that they use the curved pusher.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
The customer said that the option filter would not deploy.They said that they use the curved pusher.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.Quality engineer and complaint analyst reviewed the sample returned from the customer.The customer returned the delivery catheter sheath, the dilator, and the pusher wire inserted through the cartridge.The filter was found inside the delivery catheter sheath approximately 58.0cm from the hub.Damage to the catheter sheath was also observed.The analyst cut the sheath to remove the filter and remnants of the liner were observed on the hook of the filter.Therefore, this complaint was confirmed.Capa c-2020-052, investigate root cause and corrective action of this issue.
Event or Problem Description
The customer said that the option filter would not deploy.They said that they use the curved pusher.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Common Device Name: OPTION ELITE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 14488893
• Report Number: 0001625425-2022-01010
• Device Sequence Number: 4975301
• Product Code: DTK
• UDI-Device Identifier: 00886333222346
• UDI-Public: 00886333222346
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2022

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 Expiration Date: 07/06/2024
• Device Model Number: 352506100E
• Device Catalogue Number: 352506100E
• Device Lot Number: 11374707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/16/2022
• Supplement Date Received by Manufacturer: 05/16/2022; 05/16/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/27/2022; 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown