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U.S. Department of Health and Human Services

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

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CORDIS CASHEL OPTEASE RETR FILTER 55 JUGULAR FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466F220AJ
Device Problems Material Frayed (1262); Catheter (3038); Tip (3123); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2018
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan. The product is available for evaluation and testing. However, the product has not been returned as of to date. Additional information will be submitted within 30 days upon receipt.

 
Event Description

During an interventional endovascular procedure for placement of a 55 cm. Optease retr. Inferior vena cava (ivc) filter jugular, the physician attempted insertion of the sheath but the distal end of the sheath became frayed. Therefore, the product was replaced with another optease filter and it was inserted from the femoral approach without any issue. There was no reported patient injury.

 
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Brand NameOPTEASE RETR FILTER 55 JUGULAR
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 Key7703021
MDR Text Key114558618
Report Number9616099-2018-02258
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/14/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2019
Device Catalogue Number466F220AJ
Device LOT Number17539623
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/21/2016
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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