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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 352506100E
Device Problem Activation Problem (4042)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/24/2018
Event Type  malfunction  
Manufacturer Narrative
The investigation is on-going, and a follow-up report will be submitted once the evaluation is complete.
 
Event Description
With the patient in a prone position, an option elite 100cm was delivered via the popliteal vein through either a 8 or 9 fr sheath post dvt thrombectomy procedure. Upon deployment the filter did not expand and remained in a closed configuration. The patient was paced supine, access was achieved through the right ij and the filter was retrieved. Once retrieved and placed on the back table, the filter eventually expanded. No fibrin band was detected on the filter and it appeared to be intact.
 
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Brand NameOPTION IVC FILTER
Type of DeviceRETRIEVABLE 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 Key7912045
MDR Text Key122162972
Report Number1625425-2018-00155
Device Sequence Number1
Product Code DTK
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K143405
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/01/2005,10/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number352506100E
Device Lot NumberQ1218875
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received01/14/2005
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 Initial

Patient Treatment Data
Date Received: 09/26/2018 Patient Sequence Number: 1
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