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

Model Number 352506070E

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Sample was returned for evaluation.A follow-up report will be submitted once the investigation has been completed.

Event Description

Filter deployed, but it wouldn't open.

Manufacturer Narrative

The customer returned the delivery catheter sheath, dilator, and pusher wire for evaluation.Dilator and pusher wire could be advanced through and removed from the delivery catheter sheath without resistance.The filter and cartridge was not returned.Without the filter or cartridge to review, the complaint cannot be confirmed.

Event Description

Filter deployed, but it wouldn't open.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: RETRIEVABLE IVC FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12320641
• MDR Text Key: 268025892
• Report Number: 0001625425-2021-01064
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• Combination Product (y/n): N
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2024
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11347088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1