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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 Cannula, Inner (749); Partial Blockage (1065)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/13/2020
Event Type  Malfunction  
Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance. This device is available for analysis but has not yet been received. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, a 55 optease retrievable vena cava filter was intended to be used to perform a vena cava filter implantation with deep vein thrombosis (dvt) of the lower extremity. The catheter sheath was used to perform an angiography. After the catheter sheath was placed below the opening of the renal vein, it was found that the contrast agent could not be injected and there was an obvious blockage was obtained in the cavity. Therefore, the operation was suspended and a new optease filter was used to proceed with the operation. There was no reported patient injury. The device will be returned for evaluation.

 
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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 Key9716788
MDR Text Key199860734
Report Number9616099-2020-03525
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,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466F210A
Device Catalogue Number466F210A
Device LOT Number17886081
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/24/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/10/2019
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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