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

Model Number 352506070E

Device Problems Difficult to Open or Close (2921); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2022

Event Type  malfunction  

Manufacturer Narrative

Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.

Event Description

Case 2: (b)(6) 2022 dr.(b)(6) ivc jug approach, filter did not open up upon deployment.Brought patient back next day and place competitor filter.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: OPTION ELITE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 15538502
• MDR Text Key: 306627241
• Report Number: 0001625425-2022-01109
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11398055
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other