BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMPIRA NC RX PTCA DILATATION CATHETER 3.0 X 6

    MDR report key: 4289940 · Received November 25, 2014

    Report

    Report Number
    3004036480-2014-00004
    Event Type
    Injury
    Date Received
    November 25, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 27, 2014
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "THE REPORT FROM THE SALES REP INFORMS THAT HE RECEIVED A CALL THAT REPORTED AN EVENT THAT OCCURRED WITH AN EMPIRA NC ON THURSDAY, (B)(6) . AN (B)(6) YEAR OLD MALE PATIENT WITH A 3.5MM X 16MM PROMUS STENT WAS BEING TREATED FOR RESTENOSIS. PATIENT HAD COMORBITIES AND WAS ON PLAVIX. HEAVILY CALCIFIED LESION WAS TREATED WITH ATHERECTOMY UTILIZING THE CSI DIAMONDBACK DEVICE. FOLLOWING ATHERECTOMY THE PHYSICIAN ATTEMPTED HIGH PRESSURE DILATATION OF THE LESION WITH A BOSTON SCIENTIFIC PTCA CATHETER. THE RESULTS WERE SUBOPTIMAL SO AN EMPIRA NC, 3.0MM X 6MM WAS SELECT TO DILATE THAT LESION. THE BALLOON WAS INFLATED ABOVE NOMINAL/RATED BURST WHILE THE LESION RESISTED DILATATION. THE EMPIRA NC RUPTURED AND THEN ADHERED TO THE LESION AND STENT. DR. (B)(6) ATTEMPTED FOR HOURS TO REMOVE THE EMPIRA FROM THE LESION/STENT AND RETRIEVE THE BALLOON CATHETER FROM THE PATIENT'S CORONARY ARTERY. NUMEROUS TECHNIQUES WERE USED. AFTER MULTIPLE ATTEMPTS THE EMPIRA NC CATHETER SEPARATED LEAVING THE DISTAL END OF THE CATHETER AND RUPTURED BALLOON IN THE PATIENT. THE PATIENT WAS TAKEN TO SURGERY AND THE REMAINING CATHETER WAS SURGICALLY REMOVED. THE PATIENT TOLERATED THE SURGICAL PROCEDURE AND IS RECOVERING. THE PROXIMAL PORTION OF THE EMPIRA NC WAS DISPOSED WITH MEDICAL WASTER AT THE END OF THE PROCEDURE. THE DISTAL PORTION OF THE CATHETER AND RUPTURED BALLOON THAT WAS SURGICALLY RETRIEVED FROM THE PATIENT IS CURRENTLY HELD AS A SURGICAL SPECIMEN AT MERCY HOSP. THE PATIENT'S FAMILY IS REQUESTING THAT THE EMPIRA NC REMAINS BE EXAMINED BY AN INDEPENDENT INVESTIGATOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766307 EMPIRA NC RX PTCA DILATATION CATHETER 3.0 X 6 CATHETER, PTCA LOX CREGANNA-TACTX MEDICAL 75R06300N CE0003166

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R