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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 Problems Failure to Align (2522); Material Twisted/Bent (2981)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); No Known Impact Or Consequence To Patient (2692)
Event Date 08/13/2018
Event Type  Injury  
Manufacturer Narrative
The catalog number is unknown, if received it will be provided. Complaint conclusion: filter placement is not available. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt of the filter. The filter remains implanted; thus, unavailable for analysis. The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed. The trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated. The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart. Without procedural films for review, the filter tilt reported could not be confirmed. Additionally, the timing and mechanism of the filter tilt is unknown. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. Without procedural films or images for review the reported event(s) could not be confirmed. Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken. Should additional information become available, the file will be updated accordingly.
 
Event Description
As reported by the legal department, the patient underwent placement of the trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt of the filter. As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further 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 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 Key7963264
MDR Text Key123669776
Report Number1016427-2018-01933
Device Sequence Number0
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/30/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received03/17/2019
Was Device Evaluated by Manufacturer? No
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: 10/12/2018 Patient Sequence Number: 1
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