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

Catalog Number 352506070E

Device Problems Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

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

Event Date 12/08/2019

Event Type  malfunction  

Manufacturer Narrative

Sample device was received for evaluation by the manufacturer on 12/20/2019, then sent out for sterilization and returned on 01/02/2020.The complaint is currently being investigated.Follow-up report with additional information will be provided by 01/17/2020.

Event Description

The option elite filter legs deployed unevenly and a couple of the legs were tangled.Used a snare to remove both filters.Only the filters are being send back.

Manufacturer Narrative

Sample device evaluation is in progress.A follow up report with additional information will be provided by 1/27/2020.

Manufacturer Narrative

An evaluation of the returned sample device was performed.The investigation was limited since the cartridge, deliver catheter sheath, dilator or pusher were not returned with the unloaded filter.The filter was placed in warm water and the legs uncrossed within 5 seconds.The device analysis could not duplicate the issue experienced by customer.No further analysis could be conducted and no root cause could be conclusively determined.If additional information is provided in the future, the issue will be re-evaluated as needed.

• 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: 9554683
• MDR Text Key: 184864936
• Report Number: 1625425-2020-00014
• 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: 01/01/2005,12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2022
• Device Catalogue Number: 352506070E
• Device Lot Number: 11272503
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other