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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problems Filter (816); Filtration Problem (2941); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis (2100)
Event Date 05/12/2017
Event Type  Injury  
Manufacturer Narrative

As reported by the legal team, the plaintiff underwent placement of defendants' optease vena cava filter on or about (b)(6) 2013 in (b)(6). The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, blood clots, clotting and occlusion of the ivc. As a direct and proximate result of these malfunctions, the plaintiff suffered injuries and damages, which require or required medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer medical expenses, pain and suffering, and other damages. The device was not returned for analysis. A device history record (dhr) review could not be conducted as the sterile lot number was not provided. Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made. 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. Thrombus in the filter does not represent a device malfunction. Thrombosis in the filter is a well-known potential complication. Factors that may have influenced the event include patient, pharmacological and lesion. 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 team, the plaintiff underwent placement of defendants' optease vena cava filter on or about (b)(6) 2013 in (b)(6). The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, blood clots, clotting and occlusion of the ivc. As a direct and proximate result of these malfunctions, the plaintiff suffered injuries and damages, which require or required medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer medical expenses, pain and suffering, and other damages.

 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tp
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tp
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6604868
MDR Text Key76434264
Report Number1016427-2017-00318
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
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 07/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/01/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2015
Device MODEL Number466FXXXX
Device Catalogue Number466F220A
Device LOT Number15707198
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/12/2017
Event Location No Information
Date Manufacturer Received07/03/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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