BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRA NC RX PTCA BALLOON DILATION CATHETER

    MDR report key: 2709352 · Received August 20, 2012

    Report

    Report Number
    3004036480-2012-00005
    Event Type
    Malfunction
    Date Received
    August 20, 2012
    Date of Event
    July 12, 2012
    Report Date
    August 14, 2012
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE REVIEWED AND THERE IS NO OBJECTIVE EVIDENCE TO SUGGEST THAT THE DEVICE MAY HAVE BEEN RELEASED WITH NON-CONFORMITIES RELATED TO THE NATURE OF THIS COMPLAINT. THE DEVICE MET SPECIFICATIONS PRIOR TO INVESTIGATION. THE DEVICE IS EXPECTED TO BE RETURNED TO CREGANNA-TACTX, BUT HAS NOT YET BEEN RECEIVED ((B)(4)).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE SHAFT OF BALLOON CATHETER BROKE AFTER DILATION WITH 16-18 ATM AT FIRST USE. THE PROCEDURE WAS PROLONGED ABOUT THREE HOURS. THE DILATION CATHETER WAS USED FOR POST-DILATION OF A DRUG-ELUTING STENT IMPLANTED IN THE RIGHT CORONARY ARTERY. DURING FIRST INFLATION, THE SHAFT OF THE DEVICE BROKE INTO TWO PIECES. THE PROXIMAL SEGMENT WAS EASILY RETRIEVED. THE DISTAL SEGMENT WAS RETRIEVED BY USING A SPECIAL RETRIEVING SYSTEM (LOOP). THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A DIFFERENT, NON-EMPIRA BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPIRA NC RX PTCA BALLOON DILATION CATHETER PTCA BALLOON CATHETER LOX CREGANNA-TACTX MEDICAL 75R10350N CE0000834

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R