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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL 466P306X CATHETER, INTRAVASCULAR, DIAGNOSTIC

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CORDIS CASHEL 466P306X CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 466P306X
Device Problem Complete Blockage (1094)
Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100)
Event Date 01/25/2017
Event Type  Injury  
Manufacturer Narrative

Occupation: other, senior counsel, litigation. (b)(4).

 
Event Description

As reported by the legal brief, patient underwent placement of a trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, occlusion of the ivc filter, thrombosis, filter cannot be retrieved, and post-thrombotic syndrome due to the filter failing. As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical are and treatment. As a further and proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other malfunctions.

 
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Brand Name466P306X
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
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 Key8289038
MDR Text Key134493834
Report Number1016427-2019-02465
Device Sequence Number0
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK020316
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 04/05/2019
2 DeviceS WERE Involved in the Event: 1   2  
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 HEALTH PROFESSIONAL
Device MODEL Number466P306X
Device Catalogue Number466P306X
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 Received04/01/2019
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 Initial

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