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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
Catalog Number 466C210F
Device Problems Crack (1135); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2019
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17827956 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, the tip-end of two 10f optease retrieval catheters were noted to be fractured, when the catheter was being flushed before use. There was no reported patient injury. The devices were stored per the instructions for use (ifu). There were no anomalies noted to the packaging of the device and the devices were prepped as per the ifu. There was no unusual force used at anytime. The procedure was completed using another device.

 
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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 Key8682310
MDR Text Key147463787
Report Number9616099-2019-03002
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/10/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number466C210F
Device LOT Number17827956
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/17/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/04/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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