Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 OPTION ELITE RETRIEVABLE 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 OPTION ELITE RETRIEVABLE VENA CAVA FILTER Back to Search Results
Model Number 352506070E
Device Problems Difficult or Delayed Positioning (1157); Difficult to Open or Close (2921)
Patient Problem Failure of Implant (1924)
Event Date 10/01/2021
Event Type  malfunction  
Event Description
Doing a filter placement via jugular access and the filter was a little tough to push through the sheath and when it came out of the sheath it didn't open.We resheathed it and took it out of the patient.When we opened a second filter it pushed easily and opened as it should.
 
Manufacturer Narrative
The device was returned, and evaluation is anticipated but had not yet begun.A follow-up report will be submitted once the device has been evaluated.
 
Manufacturer Narrative
Customer returned the device, with the filter stuck in the delivery catheter sheath approximately 63 cm from the stain relief.The dilator and cartridge attached with the delivery catheter sheath.The filter was encased in the linear, also identified that the inner sheath was delaminated from the catheter sheath.During review, the delivery catheter sheath was cut open which revealed that the linear delaminated from the sheath.This resulted in the filter being unable to advance.Therefore the complaint was confirmed.Multiple complaints were received from customers regarding this issue.Capa c-2021-052 was initiated to investigate root causes and corrective action.
 
Event Description
Doing a filter placement via jugular access and the filter was a little tough to push through the sheath and when it came out of the sheath it didn't open.We resheathed it and took it out of the patient.When we opened a second filter it pushed easily and opened as it should.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OPTION ELITE RETRIEVABLE VENA CAVA FILTER
Type of Device
OPTION 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 Key12715535
MDR Text Key280872635
Report Number0001625425-2021-01111
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00886333217519
UDI-Public00886333217519
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number352506070E
Device Catalogue Number352506070E
Device Lot Number11378921
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-