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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 Problem Difficult to Remove (1528)
Patient Problems Pain (1994); Thrombosis (2100); Cardiac Tamponade (2226); Injury (2348); Disability (2371)
Event Date 10/01/2017
Event Type  Injury  
Manufacturer Narrative

Occupation: other, senior counsel, litigation. Additional information is pending and will be submitted when received.

 
Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, after the first attempt to remove the filter, the patient ultimately had open heart surgery to remove the filter. As a result of the malfunction, the patient has or may continue to suffer life-threatening injuries and damages and require extensive medical care and treatment. The patient has and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses. The patient will require continued close monitoring of the filter, medications to reduce the risks of new blood clots.

 
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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
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8892724
MDR Text Key154416388
Report Number1016427-2019-03169
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
Report Date 10/11/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466FXXXX
Device Catalogue Number466FXXXX
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2019
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? No
Type of Device Usage

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