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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER; RETRIEVABLE IVC FILTER Back to Search Results
Model Number 352506070E
Device Problem Activation Problem (4042)
Patient Problem Insufficient Information (4580)
Event Date 06/22/2021
Event Type  malfunction  
Manufacturer Narrative
Sample was returned for evaluation.A follow-up report will be submitted once the investigation has been completed.
 
Event Description
Filter never deployed, legs were caught together by plastic.
 
Event Description
Filter never deployed, legs were caught together by plactic.
 
Manufacturer Narrative
A review of the sample found delamination of the sheath ptfe liner, confirming the complaint.Capa 1026 was initiated to investigate root causes for the filter getting caught in the sheath and/or scraping off the sheath lining during filter deployment.The investigation found the interaction between the sharp filter features (legs) with the sheath lining causes damage to the sheath lining during filter deployment.Corrective actions to modify sheath lining material selection and/or manufacturing processes to improve device performance are currently in progress.
 
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Brand Name
OPTION ELITE RETRIEVABLE VENA CAVA FILTER
Type of Device
RETRIEVABLE IVC FILTER
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
MDR Report Key12137574
MDR Text Key262896979
Report Number0001625425-2021-01018
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
Type of Report Initial,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/13/2024
Device Model Number352506070E
Device Catalogue Number352506070E
Device Lot Number11368426
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/22/2021
Initial Date FDA Received07/08/2021
Supplement Dates Manufacturer Received06/22/2021
Supplement Dates FDA Received08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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