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 Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2022
Event Type  malfunction  
Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
 
Event Description
The filter was deployed during procedure but the filter did not open/expand.The filter was then retrieved and physician attempted to open it on back table (still would not open) and a new one was placed successfully.
 
Event Description
The filter was deployed during procedure but the filter did not open/expand.The filter was then retrieved and physician attempted to open it on back table (still would not open) and a new one was placed successfully.
 
Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.Quality engineer and complaint analyst reviewed the sample returned from the customer.Customer returned filter (filter was removed from the cartridge) which was visually inspected and did not find any damage and filter opened normally without any issue.Product complaint mode could not be duplicated during the evaluation, because customer did not return any other supporting devices such as delivery catheter sheath, dilator, pusher wire and/or cartridge.Based on the evaluation of the returned device, this complaint could not be confirmed.Since the complaint was not confirmed, no corrective action is required at this time because a manufacturing defect could not be confirmed.
 
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
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key16016904
MDR Text Key307976188
Report Number0001625425-2022-01164
Device Sequence Number1
Product Code DTK
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 User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2022
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 Number11432486
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-