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U.S. Department of Health and Human Services

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

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CORDIS CASHEL 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problems Complete Blockage (1094); Difficult to Remove (1528)
Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Vascular System (Circulation), Impaired (2572)
Event Date 07/20/2017
Event Type  Injury  
Manufacturer Narrative
Occupation: other, senior counsel, litigation.
 
Event Description
As reported by the legal brief, the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, two failed retrieval attempts. The first retrieval attempt was a routine removal in which the filter had become tilted and embedded in the vena cava wall. The second retrieval attempt was a complex percutaneous using a dual approach; however, the filter hook was embedded in the vena cava wall. Additional evidence shows that the patient now suffers chronic filter occlusion and has been diagnosed with post-thrombotic syndrome. The patient suffered life-threatening injuries and damages and required extensive medical care and treatment. As a further and proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering, and other damages.
 
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Brand Name466FXXXX
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 Key8288929
MDR Text Key134495757
Report Number1016427-2019-02464
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 company representative,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
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 Received04/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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