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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. OPTION ELITE FILTER, INTRAVASCULAR, CARDIOVASCULAR

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ARGON MEDICAL DEVICES, INC. OPTION ELITE FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 352506070E
Device Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2016
Event Type  malfunction  
Event Description
When placing the ivc filter in the vessel, it would not deploy.
 
Event Description
When placing the ivc filter in the vessel, it would not deploy.
 
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Brand NameOPTION ELITE
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
1445 flat creek rd.
athens TX 75751
MDR Report Key6145093
MDR Text Key195042468
Report Number6145093
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number352506070E
Device Lot NumberQ954318
Other Device ID Number2019-08-30
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/07/2016
Event Location Hospital
Date Report to Manufacturer11/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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