BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRA RX PTCA DILATATION CATHETER

    MDR report key: 2449875 · Received February 2, 2012

    Report

    Report Number
    3008950987-2012-00003
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    January 4, 2011
    Report Date
    February 2, 2012
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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. THE POTENTIAL ROOT CAUSE IS THAT THE LESION WAS NOT SIZED CORRECTLY PRIOR TO PERFORMING TH PROCEDURE. THIS IS SUPPORTED BY THE REDUCTION IN BALLOON DIAMETER FOR EACH SUBSEQUENT ATTEMPT TO CROSS THE LESION. DISSECTIONS SUCH AS THIS OCCUR COMMONLY AND UNPREDICTABLY. DURING PRE-DILATATION DISSECTIONS ARE TYPICALLY RELATED TO THE UNDERLYING NATURE OF THE LESION BEING TREATED RATHER THAN A SPECIFIC DEVICE.

    Description of Event or Problem · 1

    THE PHYSICIAN TREATED THE PT WITH A LONG CALCIFIED LESION IN CIRCUMFLEX CORONARY ARTERY WITH ANGIOPLASTY. THE PHYSICIAN BEGAN WITH AN EMPIRA 2.5X20, WHICH DID NOT CROSS THE LESION. HE TRIED AGAIN WITH A MINITREK BALLOON (ABBOTT) 2.5X20 WHICH DID NOT CROSS EITHER. THEN HE USED AN EMPIRA 2X15 WITHOUT SUCCESS. HE TRIED AGAIN WITH A MINITREK 2X15 WITHOUT SUCCESS ALTHOUGH HE WAS ABLE TO ADVANCE A LITTLE BIT MORE. THE PHYSICIAN TRIED AGAIN WITH AN EMPIRA 1.5X15 AND WAS NOT ABLE TO CROSS AGAIN. HE THEN USED AN APEX BALLOON (BSC) 1.2X6 AND THIS BALLOON CROSSED THE LESION. IN AN ATTEMPT TO DILATE MORE OF THE STENOSIS HE USED AN EMPIRA 2.5X10 WHICH DID NOT CROSS AND CAUSED A DISSECTION IN THE ARTERY. A MINITREK BALLOON 2.5X10 WAS USED WHICH CROSSED THE LESION WITHOUT DIFFICULTY. A STENT WAS PLACED TO TREAT THE DISSECTION, THE PT WAS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPIRA RX PTCA DILATATION CATHETER LOX, CATHETERS PTCA LOX CREGANNA-TACTX MEDICAL 85R10250S CE0000252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention