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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES OPTION RETRIEVABLE VENA CAVA FILTER SYSTEM RETRIEVABLE IVC FILTER Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 08/04/2017
Event Type  Injury  
Manufacturer Narrative
Sample is unavailable for evaluation. Without such evidence to review, the complaint cannot be confirmed. If additional information is provided in the future, a follow-up report will be submitted.
 
Event Description
According to the notice received by way of a civil action complaint, the patient was prescribed and implanted with an option vena cava filter on or about (b)(6) 2017 by dr. (b)(6) at (b)(6) medical center in (b)(6). The complaint alleges there was perforation. The filter was not retrieved. Argon¿s attorneys are attempting to gather additional information.
 
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Brand NameOPTION RETRIEVABLE VENA CAVA FILTER SYSTEM
Type of DeviceRETRIEVABLE IVC FILTER
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
gina liu
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key12053627
MDR Text Key258009683
Report Number0001625425-2021-01006
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/29/2021
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

Patient Treatment Data
Date Received: 06/23/2021 Patient Sequence Number: 1
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