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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER Back to Search Results
Catalog Number 352506070E
Device Problems Defective Component (2292); Activation Problem (4042)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2020
Event Type  Malfunction  
Manufacturer Narrative

The sample device is indicated as available for evaluation. However, as of the date of this report, the device has not yet been returned. A follow-up report will be provided by 3/27/2020.

 
Event Description

Item 352506070e filt opt vncv 5fx70 for 1 each ¿ lot number 11289240. (b)(6) states ¿defective, filter did not deploy¿. Please let me know what is needed to get this returned and a replacement sent to (b)(6) or just credit if that is easier.

 
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Brand NameOPTION IVC FILTER
Type of DeviceRETRIEVABLE INFERIOR VENA CAVA FILTER
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer (Section G)
ARGON MEDICAL DEVICES INC.
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75751
2144368995
MDR Report Key9764221
MDR Text Key186123717
Report Number1625425-2020-00193
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)Y
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
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,02/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/27/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352506070E
Device LOT Number11289240
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received01/14/2005
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 Unkown

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