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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER RETRIEVABLE IVC FILTER Back to Search Results
Model Number 352506070E
Device Problem Activation Problem (4042)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/26/2020
Event Type  Malfunction  
Manufacturer Narrative

The sample device is indicated as unavailable for evaluation. Without such evidence to review, a root cause cannot be determined. If additional information is received in the future, a follow-up report will be provided.

 
Event Description

Attempted to deploy the filter from a jugular approach, but the filter would not deploy. Filter still remained in the cartridge. Staff threw away all of the materials, but took a picture of the label packaging that included lot number.

 
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Brand NameOPTION ELITE RETRIEVABLE VENA CAVA FILTER
Type of DeviceRETRIEVABLE IVC FILTER
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key10157491
MDR Text Key196391881
Report Number1625425-2020-00352
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
PMA/PMN NumberK133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 06/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number352506070E
Device Catalogue Number352506070E
Device LOT Number11304185
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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