BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRA NC RX PTCA DILATATION CATHETER

    MDR report key: 2815299 · Received October 23, 2012

    Report

    Report Number
    3004036480-2012-00008
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 23, 2012
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. DEVICE ANALYSIS IS PENDING RECEIPT OF THE DEVICE.

    Description of Event or Problem · 1

    PTCA BALLOON WAS INSERTED, INFLATED, DEFLATED UPON REMOVAL OF THE DEVICE, THE PHYSICIAN NOTICED THE SHAFT WAS "BROKEN". HE STATED HE DID NOT FEEL ANYTHING WHEN REMOVING UNDER FLUORO, THE BALLOON WAS NOTED TO BE IN THE SHAFT OF THE CATHETER. CATHETER WAS REMOVED WITH DEVICE IN. NO HARM TO PT AND THE PROCEDURE CONTINUED. THE TARGET LESION WAS DESCRIBED AS A BIFURCATED LESION CONSISTING OF THE LAD AND THE 1ST DIAGONAL BRANCH. BOTH VESSELS SHOWED 90-95% CONCENTRICALLY STENOSED LESIONS THAT WERE CHARACTERIZED AS HEAVILY CALCIFIED. EASE OF ACCESSING/CROSSING WAS REPORTED AS "DIFFICULT TO WIRE". THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED NORMAL. THERE WAS NO REPORTED DIFFICULTY IN REMOVING THE DEVICE FROM THE PACKAGING. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU AND NO PROBLEMS WERE NOTED DURING PREP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPIRA NC RX PTCA DILATATION CATHETER LOX, CATHETER, PTCA LOX CREGANNA-TACTX MEDICAL 75R06200N CE0000536

    Patients

    Seq Age Sex Outcome Treatment
    1