BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRA RX PTCA BALLOON DILATATION CATHETER

    MDR report key: 2674585 · Received July 25, 2012

    Report

    Report Number
    3008950987-2012-00004
    Event Type
    Malfunction
    Date Received
    July 25, 2012
    Date of Event
    June 27, 2012
    Report Date
    July 25, 2012
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFG 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 SPECS PRIOR TO DISTRIBUTION. THE ROOT CAUSE IS INCONCLUSIVE DUE TO THE DEVICE NOT BEING RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE CORONARY ANGIOPLASTY, THE BALLOON RUPTURED ON INFLATION AT 6 ATM. AN INDIFLATOR WAS USED. THE BALLOON WAS BEING TRACKED FROM THE RIGHT AORTA THROUGH A SAPHENOUS VEIN GRAFT (SVG) TO THE DISTAL RCA. IN INFLATION AND BALLOON RUPTURE OCCURRED WHEN THE SVG WAS BEING ANGIOPLASTIED. BALLOON WAS WITHDRAWN; ANOTHER BALLOON WAS USED TO COMPLETE THE CASE. REPORT ONLY, NO DEVICE IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPIRA RX PTCA BALLOON DILATATION CATHETER PTCA CATHETER LOX CREGANNA-TACTX MEDICAL 85R15250S CE000031

    Patients

    Seq Age Sex Outcome Treatment
    1