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U.S. Department of Health and Human Services

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

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CORDIS CASHEL OPTEASE RETR FILTER 55 FEMORAL FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F220AF
Device Problems Material Frayed (1262); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2019
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17805598 presented no issues during the manufacturing process that can be related to the reported event. The device was not returned for analysis. A device history record (dhr) review was performed and showed that these lots of products met all the requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, a sheath and the dilator of an optease were attempted to be inserted, however the distal end of the sheath became frayed. There was no reported patient injury. Therefore it was replaced with a new optease and it could be inserted. An approach was made from the femoral artery. The device will not be returned for analysis because of an emergent procedure.

 
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Brand NameOPTEASE RETR FILTER 55 FEMORAL
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 Key8340302
MDR Text Key136170060
Report Number9616099-2019-02709
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeJA
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 03/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466F220AF
Device Catalogue Number466F220AF
Device LOT Number17805598
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/05/2018
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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