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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 Detachment Of Device Component (1104); Cannula Guide (3037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/12/2017
Event Type  Malfunction  
Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance. This device was received for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.

 
Event Description

Additional information was received and the device was received with a cut/separated at 35. 5cm from cannula hub. It was reported that the optease filter with its sheath introducer got kinked. Therefore the devices were replaced with a new 7f non cordis product and the procedure was completed successfully. There was no reported patient injury. This was a filter embolization case and an approach was made from the femoral vein. The target lesion was the inferior vena cava. The patient¿s vessel level of tortuosity and calcification was unknown. The rate of stenosis was unknown. The products were prepped according to the instruction for use (ifu). There were no difficulty noted during prep. There any damages noted to the device packaging. The product was clinically used and will be returned for analysis.

 
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Brand NameOPTEASE RETR FILTER 55 FEMORAL
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 32575
EI 32575
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6891658
MDR Text Key87646910
Report Number9616099-2017-01453
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 HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/29/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2019
Device MODEL Number466F220AF
Device Catalogue Number466F220AF
Device LOT Number17594357
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/29/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/31/2017
Event Location No Information
Date Manufacturer Received09/25/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/05/2016
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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