BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRA NC RX PTCA BALLOON DILATION CATHETER

    MDR report key: 2726243 · Received August 29, 2012

    Report

    Report Number
    3004036480-2012-00006
    Event Type
    Malfunction
    Date Received
    August 29, 2012
    Date of Event
    July 31, 2012
    Report Date
    August 28, 2012
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    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 DISTRIBUTION.

    Description of Event or Problem · 1

    DURING A 6 FRENCH RADIAL PTCA OF RIGHT CORONARY ARTERY IN A (B)(6) FEMALE, A 6 FRENCH 1.5 IKARRI TERUMO GUIDE CATHETER WAS PLACED AT THE OSTIUM. A 3X12 XIENCE (ABBT) WAS PRIMARILY PLACED WITHOUT PREDILECTION. A 3.25X10 EMPIRA NC WAS PLACED AT THE OSTIUM AND INFLATED TO 22 ATM; WAS DEFLATED AND PHYSICIAN NOTED BALLOON HAD RUPTURED. A 3.5X10 EMPIRA NC WAS UTILIZED SUCCESSFULLY. NO PT ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPIRA NC RX PTCA BALLOON DILATION CATHETER LOX, CATHETER, PTCA LOX CREGANNA-TACTX MEDICAL 75R10235N CE0000887

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR