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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 Insufficient Information (4580)
Event Date 06/22/2021
Event Type  Malfunction  
Manufacturer Narrative

Sample was returned for evaluation. A follow-up report will be submitted once the investigation has been completed.

 
Event Description

Filter never deployed, legs were caught together by plastic.

 
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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 75751
Manufacturer Contact
gina liu
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key12137574
MDR Text Key262896979
Report Number0001625425-2021-01018
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133243
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,Followup
Report Date 08/03/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number352506070E
Device Catalogue Number352506070E
Device LOT Number11368426
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/02/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated By Manufacturer? Yes
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: 07/08/2021 Patient Sequence Number: 1
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