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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL 466F220A FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL 466F220A FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F220A
Device Problems Filter (816); Difficult to Remove (1528); Retraction Problem (1536); Failure to Align (2522)
Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)
Event Date 11/09/2009
Event Type  Injury  
Manufacturer Narrative

The product was not returned for evaluation. The catalog number is unknown, if received it will be provided. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported by legal brief, the patient underwent placement of optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to: filter perforating the vena cava with significant tilt. Failed filter removal due to tilt and thrombus in filter. As a direct and proximate result, patient suffered life-threatening injuries and damages and required extensive medical care and treatment. As a further proximate result. Patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

 
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Brand Name466F220A
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8114017
MDR Text Key128715400
Report Number1016427-2018-02330
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466F220A
Device Catalogue Number466F220A
Device LOT NumberR1108035
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/05/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/28/2018 Patient Sequence Number: 1
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