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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
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ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER Back to Search Results
Model Number 352506070E
Device Problems Entrapment of Device (1212); Peeled/Delaminated (1454)
Patient Problem Insufficient Information (4580)
Event Date 01/03/2022
Event Type  malfunction  
Event Description
He found thread after inserting filter and it gets tangled in the filter hook to move the position of the filter.It looks like the inner wall of the sheath peels off.He retrieved filter and used bard and finished procedure.He wants to receive the investigation report.
 
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.
 
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
He found thread after inserting filter and it gets tangled in the filter hook to move the position of the filter.It looks like the inner wall of the sheath peels off.He retrieved filter and used bard and finished procedure.He wants to receive the investigation report.
 
Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
 
Event Description
He found thread after inserting filter and it gets tangled in the filter hook to move the position of the filter.It looks like the inner wall of the sheath peels off.He retrieved filter and used bard and finished procedure.He wants to receive the investigation report.
 
Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.The quality engineer and the complaint analyst reviewed the sample returned from the customer.The customer returned the pusher wire and the delivery catheter sheath.Visual inspection confirmed approximately 35 cm of liner delaminated from the delivery catheter sheath.The coil was also found to be not fully assembled inside the delivery catheter sheath.Therefore, this complaint was confirmed.Capa c-2021-052 was initiated to address the sheath delamination issues and the capa will identify the specific causes and corrective actions taken.
 
Event Description
He found thread after inserting filter and it gets tangled in the filter hook to move the position of the filter.It looks like the inner wall of the sheath peels off.He retrieved filter and used bard and finished procedure.He wants to receive the investigation report.
 
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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 Key13250847
MDR Text Key285993907
Report Number0001625425-2022-00924
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00886333217151
UDI-Public00886333217151
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 Other
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2022
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 Number11374710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/06/2022
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;
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