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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 10FR OPTEASE RETRIEVAL CATH. FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION 10FR OPTEASE RETRIEVAL CATH. FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466C210F
Device Problems Detachment of Device or Device Component (2907); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2019
Event Type  Injury  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17859781 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, the blue ring at the far-end of 10f optease retrieval catheter fell off after the recovery while using optease filter. The ring was removed by using the unknown guide wire and the catheter under the blockage of the balloon. There was no any patient injury and the patient¿s outcome was great. This was a case of the removal of inferior vena cava filter. There were no anomalies of the patient`s vessels. There was no vessel tortuosity. The device was stored as per the labeling. The device was prepped per the instructions for use (ifu). There was no any difficulty experienced in prepping the device. There was no visible signs of device/package damage prior to use. The device was not in an acute bend. There was no difficulty advancing the device. There was no unusual force used at any time during the procedure. The procedure was completed. Available images were reviewed. In the first image an x-ray image shows an inflated balloon, a snare device in a guide catheter and a cylindrical radiopaque object that may be the tip of a catheter. There is a graduated marker adjacent, likely located on the surface of the drape. The image appears to be in the region of the pelvis. The second image shows a gloved hand holding a possible guidewire with a separated catheter tip captured on it and a snare device within a guide catheter located on the guidewire distal to the separated catheter tip. The third image shows a gloved hand holding a guidewire with the separated catheter tip located on the guidewire. The device will be returned for evaluation.

 
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Brand Name10FR OPTEASE RETRIEVAL CATH.
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9285716
MDR Text Key166303463
Report Number9616099-2019-03337
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
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,Followup,Followup
Report Date 01/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number466C210F
Device Catalogue Number466C210F
Device LOT Number17859781
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/26/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/30/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/06/2019 Patient Sequence Number: 1
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