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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. OPTION ELITE IVC FILTER; RETRIEVABLE INFERIOR VENA CAVA FILTER
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ARGON MEDICAL DEVICES INC. OPTION ELITE IVC FILTER; RETRIEVABLE INFERIOR VENA CAVA FILTER Back to Search Results
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 12/05/2016
Event Type  malfunction  
Manufacturer Narrative
The product not returned for evaluation.No lot number was not provided.Images were provided by the sales representative, but the complaint could not be confirmed based on those images, as no obvious damage was visible.The retrieval hook, as well as the six legs and anchors, looked intact.However, in one view, one leg appears obscured by the object passing by the filter in the vessel.It is possible that the images were taken prior to the alleged fracture.
 
Event Description
Doctor retrieved an option ivc filter that was placed in (b)(6) 2010.Hook snapped off during retrieval (cook retrieval kit), was able to suction hook out.Finished retrieval with forceps.
 
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Brand Name
OPTION ELITE IVC FILTER
Type of Device
RETRIEVABLE INFERIOR VENA CAVA FILTER
Manufacturer (Section D)
ARGON MEDICAL DEVICES INC.
1445 flat creek road
athens TX 75751
Manufacturer (Section G)
ARGON MEDICAL DEVICES INC.
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75751
2144368995
MDR Report Key6223610
MDR Text Key64177212
Report Number1625425-2016-00100
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Physician
Type of Report Initial
Report Date 01/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/05/2016
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
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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