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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

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ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER Back to Search Results
Model Number 352506100E
Device Problems Connection Problem (2900); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 05/09/2021
Event Type  malfunction  
Manufacturer Narrative
The sample is indicated as available for evaluation. A follow-up report will be submitted once the sample has been received and reviewed.
 
Event Description
Distal radiopaque band came off the dilator while getting inserted into the body, and the radiopaque band traveled into the right lungs¿.
 
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Brand NameOPTION ELITE RETRIEVABLE VENA CAVA FILTER
Type of DeviceOPTION ELITE
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
gedaa hassan
1445 flat creek road
athens, TX 75751
9036759321
MDR Report Key12425404
MDR Text Key271265227
Report Number0001625425-2021-01074
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143405
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number352506100E
Device Catalogue Number352506100E
Device Lot Number11347150
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/18/2021
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: 09/03/2021 Patient Sequence Number: 1
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