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 Consequences Or Impact To Patient (2199)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going, and a follow-up report will be submitted once the evaluation is complete.

Event Description

An option elite ivc filter was deployed from the ij using the curved pusher.The filter was deployed from the cartridge using the pin and pull technique, however, the legs on the filter did not open.After the realization that the filter was not deployed properly, the physician was able to re-sheath the filter and remove the entire device.The patient did not experience any negative events after the failed ivc filter procedure.

Manufacturer Narrative

A review of the device history record was conducted and no similar concerns were found.The returned sample was reviewed in the lab with the engineering services director and the complaint analyst.The filter was returned in the end of the delivery sheath with dried bodily fluids.The delivery sheath and filter were soaked in alcohol for approximately 60 seconds and the filter was able to be deployed from the delivery sheath normally.The filter was then placed in warm water for approximately 45 seconds, and the filter was normal in appearance without any issues noted.The complaint cannot be confirmed; therefore, no definitive root cause can be identified.Additionally, it is difficult to understand how the user re-sheathed the filter.According the ifu, when the filter is pushed or advanced through the sheath, the filter cannot be moved backward through the sheath.

• 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: 7803020
• MDR Text Key: 118110102
• Report Number: 1625425-2018-00112
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• 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: Q1263319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• 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
• Patient Outcome(s): Required Intervention