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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); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/14/2019
Event Type  Malfunction  
Manufacturer Narrative

Additional information to include from section phone number: (b)(6). The products were not returned for analysis. A review of the manufacturing records could not be conducted without a lot number. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

During use, the optease ivc filter encountered resistance during the releasing process and a barbed filter on top of the sheath was noticed. There was no patient injury. Another ivc filter was used to complete the procedure. The target lesion was with thrombus but did not exhibit tortuosity, calcification or stenosis. The product was stored, handled, inspected and prepped according to the instruction for use (ifu) with nothing unusual or damages noted about the delivery sheath prior to use. The device package was not damaged. Excessive force was not used when the device was removed from the packaging. There was no excessive force used during the procedure. The device will not 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, tipperary 0000
EI 0000
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI 0000
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8603504
MDR Text Key144837064
Report Number9616099-2019-02927
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 FOREIGN
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/13/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466F210A
Device Catalogue Number466F210A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/21/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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