BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRA NC RX PTCA DILATATION CATHETER

    MDR report key: 2269390 · Received September 8, 2011

    Report

    Report Number
    3008950987-2011-00001
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 11, 2011
    Report Date
    September 8, 2011
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET RETURNED. MFG RECORDS WERE REVIEWED AND THERE WAS NO EVIDENCE TO SUGGEST THE DEVICE MAY HAVE BEEN RELEASED WITH NON-CONFORMITIES RELATED TO THE NATURE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    THE PHYSICIAN USED EMPIRA NC 3X10 MM IN A BIFURCATION, SUDDENLY A THROMBUS APPEARED IN THE LESION. HE GAVE MORE HEPARIN AND THEN GPIIBIIA AS THE THROMBUS WAS GETTING BIGGER AND THE TIMI FLOW WAS SLOWING. THE PHYSICIAN USED AN EXPORT CATHETER TO REMOVE THE THROMBUS. THE FINISHED HIS PROCEDURE BY PERFORMING THE KISSING BALLOON TECHNIQUE WITH 2 EMPIRA NC 3X10 CATHETERS. AT THE END OF THE PROCEDURE, THE PT WAS FINE AND THE THROMBUS REMOVED. PARTICLES FOUND IN THE BASKET OF THE EXPORT CATHETER AFTER THE PROCEDURE WERE NOT THROMBUS. OTHER DEVICES USED IN THIS PROCEDURE WERE 2 BMW ABBOTT GUIDE-WIRES AND ONE MEDTRONIC LAUNCHER GUIDING CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPIRA NC RX PTCA DILATATION CATHETER LOX, CATHETERS PTCA LOX CREGANNA-TACTX MEDICAL 75R10300N CE0000101

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention