BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRE NC RX PTCA DILATION CATHETER 10X3.50

    MDR report key: 3876866 · Received May 19, 2014

    Report

    Report Number
    3004036480-2014-00002
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: CARDIAC ANGIOPLASTY. DURING POST STENT INFLATION, THE BALLOON RUPTURED. AFTER BALLOON WAS REMOVED FROM PT AND INSPECTED, BALLOON HAD RIPPED OFF HYPOTUBE. ? BALLOON GOT CAUGHT ON STENT STRUT DURING INFLATION. NO REPORTED ADVERSE EVENT TO PT. PT WAS STABLE IMMEDIATELY AFTER THE EVENT.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296453 EMPIRE NC RX PTCA DILATION CATHETER 10X3.50 CATHETER, PTCA, LOX CREGANNA-TACTX MEDICAL EMPIRA CN RX PTCA CE0002419

    Patients

    Seq Age Sex Outcome Treatment
    1 Other