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

Catalog Number 352506070E

Device Problems Difficult to Remove (1528); Sticking (1597); Difficult to Advance (2920)

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

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

A guidewire, cook brand 4f catheter, and pieces of a guidewire were returned and evaluated.The proximal end of the guidewire was intact, but the distal end had unraveled.The wire was found in three pieces: one inside the 4f catheter, one in a separate bag (unraveled) and the third section through the filter.This damage could be a result of handling in the user environment or a result of a manufacturing issue (however the manufacturer of the guidewire is unknown).The portion of the wire in the filter, which had unraveled, was free to move within the lumen of the filter.The returned filter appeared correct with a regular shape and no burrs.The delivery system was not returned for evaluation.The guidewire breakage could not be confirmed to be related to the filter or delivery system.

Event Description

The doctor was placing a filter using the over the wire approach through the fem.After deployment of the filter, the bentson guide wire was caught on the filter hub.He could not push or pull the wire.They opened up from the jug and managed to remove the filter and wire that was snagged.Another filter was placed just after.

• Brand Name: OPTION ELITE IVC FILTER
• Type of Device: RETRIEVABLE INFERIOR VENA CAVA FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 6192187
• MDR Text Key: 63213323
• Report Number: 1625425-2016-00097
• 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: company representative,user f
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 352506070E
• Device Lot Number: Q991220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention