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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 Defective Device (2588)
Patient Problems Coagulation Disorder (1779); Occlusion (1984)
Event Date 09/26/2017
Event Type  Injury  
Manufacturer Narrative
According to the information received in the patient profile from (ppf), the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting, and/or occlusion of the ivc. The patient suffers from pain, and fear that the implant has moved or might cause further injury or death. The following additional information received per the medical records state that the patient has a history of right lower extremity dvt with poor response to anticoagulation therapy. The patient also has a history of diabetes, congestive heart failure, hypothyroidism, hypertension and asthma. During the implant procedure, the left common femoral vein was accessed and a vascular sheath was inserted. The ivc filter was deployed to the two-three interface. The patient tolerated the procedure well. Information is pending and will be submitted in a follow up report when received.
 
Event Description
As reported by the legal department, the patient underwent placement of the trapease vena cava filter for the treatment for a deep vein thrombosis. That filter is still in place, which is known to be dangerous and cause serious side effects. As a result of the filter installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside the body. According to the information received in the patient profile from (ppf), the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting, and/or occlusion of the ivc. The patient suffers from pain, and fear that the implant has moved or might cause further injury or death. The following additional information received per the medical records state that the patient has a history of right lower extremity dvt with poor response to anticoagulation therapy. The patient also has a history of diabetes, congestive heart failure, hypothyroidism, hypertension and asthma. During the implant procedure, the left common femoral vein was accessed and a vascular sheath was inserted. The ivc filter was deployed to the two-three interface. The patient tolerated the procedure well.
 
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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 Key8201333
MDR Text Key131585124
Report Number1016427-2018-02369
Device Sequence Number1
Product Code DQO
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 company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2019
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number466P306X
Device Catalogue Number466P306X
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 Received12/30/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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