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

Model Number 352506070E

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

The sample was returned for evaluation.A review found that the filter could be advanced through the cartridge without issue.The most likely cause of the problem experienced by the customer is that the pusher wire was not properly centered during the procedure and excessive force was used in the attempt to advance the filter evidenced by a minor kink found on the pusher wire.No corrective action will be taken since the issue was most likely the result of an event in the user facility.

Event Description

Customer called and said curved pusher wire would not pass through ivc filter cartridge and kept kinking.Customer stated it seemed as if the wire was getting caught on the filter inside the cartridge and would not pass through the apex as designed.Tm went and observed the defective device and did not see any immediate issue with the product.Tm did observe curved pusher wire did have severe kink.No patient impact was noted.

Event Description

Follow up.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: RETRIEVABLE IVC FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10162147
• MDR Text Key: 196392848
• Report Number: 1625425-2020-00354
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• Combination Product (y/n): N
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11304185
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1