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

Model Number	352506070E
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Doing a filter placement via jugular access and the filter was a little tough to push through the sheath and when it came out of the sheath it didn't open.We resheathed it and took it out of the patient.When we opened a second filter it pushed easily and opened as it should.
Additional Manufacturer Narrative
The device was returned, and evaluation is anticipated but had not yet begun.A follow-up report will be submitted once the device has been evaluated.
Additional Manufacturer Narrative
Customer returned the device, with the filter stuck in the delivery catheter sheath approximately 63 cm from the stain relief.The dilator and cartridge attached with the delivery catheter sheath.The filter was encased in the linear, also identified that the inner sheath was delaminated from the catheter sheath.During review, the delivery catheter sheath was cut open which revealed that the linear delaminated from the sheath.This resulted in the filter being unable to advance.Therefore the complaint was confirmed.Multiple complaints were received from customers regarding this issue.Capa c-2021-052 was initiated to investigate root causes and corrective action.
Event or Problem Description
Doing a filter placement via jugular access and the filter was a little tough to push through the sheath and when it came out of the sheath it didn't open.We resheathed it and took it out of the patient.When we opened a second filter it pushed easily and opened as it should.

• 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: gedaa hassan ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 12715535
• Report Number: 0001625425-2021-01111
• Device Sequence Number: 1361975
• Product Code: DTK
• UDI-Device Identifier: 00886333217519
• UDI-Public: 00886333217519
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: 07/29/2024
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11378921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/04/2021
• 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