BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1203629 · Received October 16, 2008

    Report

    Report Number
    2134265-2008-03054
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE LESION WAS 99% STENOSED AND SEVERLY CALCIFIED. THE APEX MONORAIL 15MM X 2.50MM BALLOON WAS ADVANCED TO THE LESION FOR PREDILATION. HOWEVER, UPON INFLATION, THE BALLOON RUPTURED. THE NUMBER OF INFLATIONS, INFLATION TIME, AND ATMS ARE UNKNOWN. THE BALLOON WAS REMOVED FROM THE PT INTACT. A TAXUS DRUG ELUTING STENT, WHICH THE SIZE WAS UNSPECIFIED, WAS IMPLANTED SUCCESSFULLY. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL NA LOX BOSTON SCIENTIFIC 2.5X15 MM 11478534

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDECATHETER: 8F BRITETIP| INTRODUCER SHEATH: 8F TERUMO