MAUDE Adverse Event Report: ARGON MEDICAL ARGON OPTION ELITE RETREIVABLE INFERIOR VANA CAVA FILTER; INFERIOR VENA CAVA FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/25/2018

Event Type  Injury  

Event Description

Pt here for ivc filter removal.During extraction, filter broke into 2 pieces.One piece could be extracted, the other filter piece remained in the pt's extracted filter piece had 2 prongs remaining piece had 4 prongs.For the pt's protection a new ivc filter was placed above the old remaining filter piece requires pt to return for removal and extraction once.

• Brand Name: ARGON OPTION ELITE RETREIVABLE INFERIOR VANA CAVA FILTER
• Type of Device: INFERIOR VENA CAVA FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): ARGON MEDICAL; 2600 dallas parkway; suite 440; frisco TX 75034
• MDR Report Key: 7984487
• MDR Text Key: 124881680
• Report Number: MW5080701
• Device Sequence Number: 0
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 44