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

Model Number 352506070E

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2020

Event Type  malfunction  

Event Description

Unable to deploy argon medical devices, inc.Option elite retrievable vena cava filter lodged in catheter.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 10605517
• MDR Text Key: 209140346
• Report Number: 10605517
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 352506070E
• Device Lot Number: 11279012
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1