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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETR FILTER 55 FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL OPTEASE RETR FILTER 55 FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F210A
Device Problems Filter (816); Difficult to Insert (1316); Material Puncture/Hole (1504); Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2017
Event Type  Malfunction  
Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt. A device history record (dhr) review of lot 17543882 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.

 
Event Description

As reported, after the optease retrieval filter was put into the sheath, the side of the filter punctured through the delivery sheath. It was then withdrawn and it was found that the whole filter was compressed. There was no reported patient injury. The product was clinically used and will be returned for analysis.

 
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Brand NameOPTEASE RETR FILTER 55
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
MDR Report Key7052648
MDR Text Key93300896
Report Number9616099-2017-01608
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,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2019
Device MODEL Number466F210A
Device Catalogue Number466F210A
Device LOT Number17543882
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 Received12/20/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/23/2016
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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