BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)

    MDR report key: 3050186 · Received April 3, 2013

    Report

    Report Number
    3005462046-2013-00013
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    January 18, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    NWX
    PMA / PMN Number
    P050018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT INFORMATION IS UNKNOWN. THE HOSPITAL DECLINED TO PROVIDE THE PATIENT INFORMATION. TE BURST PRESSURE FOR THE ANGIOSCULPT DEVICE WAS NOT REPORTED. IT IS UNKNOWN IF THE DEVICE LEAKED ABOVE THE RATED BURST PRESSURE (RBP) OF 20 ATM. AS A CONSERVATIVE MEASURE, AN MDR IS BEING SUBMITTED IN ABUNDANCE OF CAUTION. THE ANGIOSCULPT DEVICE WAS NOT RETURNED BY THE HOSPITAL, THUS UNABLE TO EVALUATE DEVICE.

    Description of Event or Problem · 1

    A 1.5 MM AND A 1.75 MM ROTOBLATOR (MANUFACTURED BY BOSTON SCIENTIFIC) WERE USED TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) LESION. A 2.5 MM ANGIOSCULPT DEVICE WAS USED AND AT THE BEGINNING OF BALLOON INFLATION, LEAKAGE OF CONTRAST MEDIA WAS FOUND. ANOTHER 2.5MM ANGIOSCULPT DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135547 ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX) NWX ANGIOSCORE, INC. 2001-2510 F12050027

    Patients

    Seq Age Sex Outcome Treatment
    1