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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL 10FR OPTEASE RETRIEVAL CATH. FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL 10FR OPTEASE RETRIEVAL CATH. FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466C210F
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Catheter (3038); Tip (3123)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/03/2018
Event Type  Injury  
Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance. This device is available for analysis but has not yet been received. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, during the operation, the yellow tip of the optease retrieval catheter fell off in the patient's body. Additional information was received and there was difficulty withdrawing the device. The tip of the device was not retrieved; the patient seemed in normal condition. The target lesion is the inferior vena cava and the procedure is for embolism. There were no anomalies noted when the device was removed from the package. The device was prepped according to the instruction for use (ifu) with no anomalies noted during prep. There were no difficulty tracking the device towards the lesion. There were no difficulty crossing the lesion. There were no kinks observed on the device. There were no excessive force used during the procedure. There is no procedural video available. The device is available for analysis. No other information was provided.

 
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Brand Name10FR OPTEASE RETRIEVAL CATH.
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 32575
EI 32575
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 Key7476463
MDR Text Key107008049
Report Number9616099-2018-02103
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 07/24/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/01/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2020
Device MODEL Number466C210F
Device Catalogue Number466C210F
Device LOT Number17726923
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/03/2018
Event Location No Information
Date Manufacturer Received07/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/16/2017
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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