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

Model Number 352506070E

Device Problems Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/02/2022

Event Type  malfunction  

Event Description

Jugular approach when placing filter.Upon deploying-filter legs did not properly deploy.Piece of material stuck on filter when removed from patient/procedure.Physician placed second optionelite suprarenal with no issue.Not sure at this time of retrieval plan.

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.

Manufacturer Narrative

Sample is indicated as returned.As of the date of this report, sample has not been investigated.A follow-up report will be submitted once the sample has been reviewed.

Event Description

Case 1: jugular approach when placing filter.Upon deploying-filter legs did not properly deploy.Piece of material stuck on filter when removed from patient/procedure.Physician placed second optionelite suprarenal with no issue.Not sure at this time of retrieval plan.

Manufacturer Narrative

A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.Quality engineer, manufacture engineer and complaint analyst reviewed the sample returned from the customer.Customer returned delivery catheter sheath, dilator, pusher wire and filter (filter removed from the cartridge) in the cartridge.Upon investigation, it was found that plastic was removed from the delivery catheter sheath and wrapped up the filter causing filter to not deploy and complaint was confirmed.Capa c-2020-052 will investigate root cause and corrective action of this issue.

Event Description

Case 1: jugular approach when placing filter.Upon deploying-filter legs did not properly deploy.Piece of material stuck on filter when removed from patient/procedure.Physician placed second optionelite suprarenal with no issue.Not sure at this time of retrieval plan.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: 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: 15869357
• MDR Text Key: 304359387
• Report Number: 0001625425-2022-01139
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11440172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other