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

Model Number 352506070E

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

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

Event Date 07/10/2021

Event Type  malfunction  

Event Description

When placing ivc (inferior vena cava) filter, the filter would not push easily through the sheath.Pulled the sheath back and cut the sheath where filter was stuck.The filter was visualized to have plastic holding the feet of the filter together.New sheath and new filter utilized and deployed properly.No harm to pt.Procedure successful.

• 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: 12202097
• MDR Text Key: 262660503
• Report Number: 12202097
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11356485
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32120 DA
• Patient Weight: 116