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

Model Number 466P306X

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

Patient Problems Chest Pain (1776); Respiratory Distress (2045)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the plaintiff at all times relevant to this action was a citizen and resident of the state of (b)(6).The plaintiff underwent placement of defendants' trapease vena cava filter on or about (b)(6) 2010.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, severe and constant chest pains and compromised respiratory system.As a direct and proximate result of these malfunctions, the plaintiff suffered serious injuries and damages and will require extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.The product was not returned for evaluation as it remains implanted.The abovementioned product¿s catalog and lot numbers are not currently available.Without a lot number to conduct a device history record (dhr) review, it is not possible to determine if the reported failure could be related to the manufacturing process.The trapease 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.There are possible patient and pharmacological factors that may have contributed to the reported events of severe and constant chest pains and compromised respiratory system.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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 brief, the plaintiff at all times relevant to this action was a citizen and resident of the state of (b)(6).The plaintiff underwent placement of defendants' trapease vena cava filter on or about (b)(6) 2010.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, severe and constant chest pains and compromised respiratory system.As a direct and proximate result of these malfunctions, the plaintiff suffered serious injuries and damages and will require extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• Manufacturer (Section G): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6362801
• MDR Text Key: 68464405
• Report Number: 1016427-2017-00199
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/31/2017
• Date Manufacturer Received: 01/31/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Life Threatening