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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. OPTION IVC FILTER; RETRIEVABLE INFERIOR VENA CAVA FILTER
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ARGON MEDICAL DEVICES INC. OPTION IVC FILTER; RETRIEVABLE INFERIOR VENA CAVA FILTER Back to Search Results
Catalog Number 352506070E
Device Problem Activation Problem (4042)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation and no images or videos have been provided of the filter in-vivo, so the complaint cannot be confirmed.If additional information is provided in the future, this issue will be re-evaluated as needed.
 
Event Description
The filter would not deploy from the cartridge.Physician tried to deploy multiple times but it would not deploy from cartridge.
 
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Brand Name
OPTION 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 Key9884375
MDR Text Key186747691
Report Number1625425-2020-00244
Device Sequence Number1
Product Code DTK
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/01/2005,03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number352506070E
Device Lot Number11280286
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received03/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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