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

Model Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, chest pain and shortness of breath.The information also indicated that as a direct and proximate result of this malfunction, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment and 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.There is currently no additional information available.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.Chest pain and shortness of breath do not indicate a device malfunction; rather patient and pharmacological factors may have contributed to these events.With the limited information provided and no post implant imaging available for review the reported events could not be confirmed or further clarified, nor is it possible to establish a relationship between the reported event and the device.Given the limited information currently available for review, there is nothing to suggest that a malfunction in 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 team, 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, severe and persistent chest pain, and shortness or breath.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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7444176
• MDR Text Key: 105962040
• Report Number: 1016427-2018-01405
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/22/2018
• Date Manufacturer Received: 03/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening