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

Catalog Number 466P306X

Device Problem Failure to Align (2522)

Patient Problem Stenosis (2263)

Event Date 12/26/2017

Event Type  Injury  

Manufacturer Narrative

Please note the exact event date is unknown and that the event date is the complaint awareness date.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt of the ivc filter and stenosis.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.No additional information is available.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) review could not be performed.The inferior vena cava (ivc) 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.A stenosis is an abnormal narrowing in a blood vessel.Without medical records available it is not possible to determine the location/cause of the stenosis.Without procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.The timing and mechanism of the tilt has not been reported at this time.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.Please note that this is the initial/final report for this product.

Event Description

As reported through the legal department via a legal brief, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt of the ivc filter and stenosis.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.No additional information is available.

• Brand Name: 466P306X
• Type of Device: CATHETER, 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
• MDR Report Key: 7215357
• MDR Text Key: 98083771
• Report Number: 1016427-2018-01097
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/26/2017
• Date Manufacturer Received: 12/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening