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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 or Device Component (2907); Catheter (3038); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2019
Event Type  Injury  
Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, during the recovery operation of a vena cava filter the head-end of a 10f optease retrieval catheter was used, however upon entering the thigh vein of the patient¿s body it was found out that the catheter fell off under fluoroscopy. There was no reported patient injury. The device was stored and handled per the instructions for use (ifu). The device was prepped according to the ifu. The indication for filter insertion was deep vein thrombosis (dvt). When the retrieval of the catheter entered the patient, the event occurred at femoral vein. The device was withdrawn from the patient using a non-cordis catheter. An image was available for review. The product has been returned for analysis containing an intact catheter and a complaint catheter with head tip.

 
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Brand Name10FR OPTEASE RETRIEVAL CATH.
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
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
7863138372
MDR Report Key9560967
MDR Text Key176112028
Report Number9616099-2020-03462
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,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 03/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466C210F
Device Catalogue Number466C210F
Device LOT Number17859781
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/30/2019
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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