MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. OPTION IVC FILTER; RETRIEVABLE INFERIOR VENA CAVA FILTER

Catalog Number 352506070E

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

Sample device was returned to manufacturer on 1/27/2020.Device evaluation is in progress.A follow-up report with additional information will be provided by 2/28/2020.

Event Description

Filter did not deploy.

Manufacturer Narrative

A review of the sample device was performed.Only the delivery sheath and pusher wire was returned, not the filter.A minor kink was found on the distal and proximal side of the pusher but could be pushed through the delivery sheath without issue.Without all parts of the device system, the complaint could not be duplicated or confirmed.Since the problem could not be determined as a design or manufacturing issue, a corrective action will not be taken at this time.

Manufacturer Narrative

The sample device was returned to argon from sterilization on 2/11/2020.Investigation is in progress.A follow-up report will be provided by 3/13/2020.

• Brand Name: OPTION IVC FILTER
• Type of Device: RETRIEVABLE INFERIOR VENA CAVA FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 9649932
• MDR Text Key: 182302716
• Report Number: 1625425-2020-00100
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): Y
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352506070E
• Device Lot Number: 11274557
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1