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

Model Number 352506070E

Device Problem Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2022

Event Type  malfunction  

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 Description

Filter deployed with wrap around end of filter so it would not expand and attach to walls of ivc.

Event Description

Filter deployed with wrap around end of filter so would not expand and attach to walls of ivc.

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 and complaint analyst reviewed the sample returned from the customer.Customer returned filter, cartridge and delivery sheath.It was found that filter was encased in the liner, and liner was removed from the catheter sheath at length approximately 1.2 cm distal side of the deliver sheath.Sample was functionally evaluated by removing the strain relief.There was kink/damage found on the delivery sheath.Delivery sheath liner was removed from the sheath and reviewed.User pushed the filter through the delivery sheath and liner was removed from the delivery sheath and caught on the filter leg.Complaint was confirmed.Capa c-2020-052 will investigate root cause and corrective action of this issue.

• 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: 16016726
• MDR Text Key: 306705869
• Report Number: 0001625425-2022-01162
• Device Sequence Number: 1
• Product Code: DTK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2024
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11357552
• 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: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other