• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARGON MEDICAL DEVICES INC. OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER Back to Search Results
Catalog Number 352506070E
Device Problem Activation Problem (4042)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2020
Event Type  Malfunction  
Manufacturer Narrative

The device has not been returned for evaluation and no images or videos have been provided of the filter in-vivo, so the complaint cannot be confirmed. If additional information is provided in the future, this issue will be re-evaluated as needed.

 
Event Description

The filter would not deploy from the cartridge. Physician tried to deploy multiple times but it would not deploy from cartridge.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOPTION IVC FILTER
Type of DeviceRETRIEVABLE INFERIOR VENA CAVA FILTER
Manufacturer (Section D)
ARGON MEDICAL DEVICES INC.
1445 flat creek road
athens TX 75751
Manufacturer (Section G)
ARGON MEDICAL DEVICES INC.
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75751
2144368995
MDR Report Key9884375
MDR Text Key186747691
Report Number1625425-2020-00244
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
Type of Report Initial
Report Date 01/01/2005,03/02/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352506070E
Device LOT Number11280286
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 Received03/02/2020
Is this a Reprocessed and Reused Single-Use Device? No

-
-