MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. OPTION ELITE INFERIOR VENA CAVA FILTER SYSTEM; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 352506070E

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2020

Event Type  malfunction  

Event Description

Upon removal of the angiographic vessel dilator from the catheter sheath introducer of an argon option elite inferior vena cava filter system, it was noted that one of the two radiopaque markers on the distal aspect of the dilator had come free off the dilator and was lodged at the distal end of the catheter sheath introducer.The dilator was then carefully removed from the sheath under fluoroscopic guidance and multiple attempts were then made with a snare device to grasp the marker, which were unsuccessful.Multiple attempts were then made to pass an 0.018 microwire through the marker and use an angioplasty balloon to capture the marker, which were also unsuccessful.At this point, due to the manipulation, the marker embolized into a small branch of the right internal iliac vein.The right internal jugular vein was then accessed and similar attempts were made to capture the marker from this approach, which were unsuccessful.Another argon option elite inferior vena cava filter system was opened and the filter was successfully deployed from the internal jugular approach.All components of the first set were sent to the manufacturer for analysis.Fda safety report id# (b)(4).

• Brand Name: OPTION ELITE INFERIOR VENA CAVA FILTER SYSTEM
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.
• MDR Report Key: 10740012
• MDR Text Key: 213440469
• Report Number: MW5097459
• Device Sequence Number: 1
• Product Code: DTK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• 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: Q1462229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1