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

Catalog Number 352506070E

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2016

Event Type  malfunction  

Event Description

When placing the ivc filter in the vessel, it would not deploy.

Event Description

When placing the ivc filter in the vessel, it would not deploy.

• Brand Name: OPTION ELITE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 6145093
• MDR Text Key: 61442637
• Report Number: 6145093
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 352506070E
• Device Lot Number: Q954318
• Other Device ID Number: 2019-08-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR