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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES OPTION RETRIEVABLE VENA CAVA FILTER RETRIEVABLE IVC FILTER Back to Search Results
Model Number 352506070E
Device Problem Activation Problem (4042)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2019
Event Type  malfunction  
Manufacturer Narrative
The sample device is indicated as available for evaluation. As of the date of this report, the sample has not yet been returned. A follow-up report will be provided once the sample has been returned and the investigation is complete.
 
Event Description
Filter did not deploy.
 
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Brand NameOPTION RETRIEVABLE VENA CAVA FILTER
Type of DeviceRETRIEVABLE IVC FILTER
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key10007487
MDR Text Key189763249
Report Number1625425-2020-00312
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00886333217151
UDI-Public00886333217151
Combination Product (y/n)N
PMA/PMN Number
K133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number352506070E
Device Catalogue Number352506070E
Device Lot Number11297000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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 Unkown

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