BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX PUSH MONORAIL

    MDR report key: 1040185 · Received May 8, 2008

    Report

    Report Number
    2134265-2008-01336
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    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 INTERVENTION PROCEDURE, BALLOON DEFLATION DIFFICULTIES OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED LEFT CIRCUMFLEX (LCX). THE 1.5X8MM APEX BALLOON WAS ADVANCED TO THE LESION, AND IT WAS NOTED THAT THE PHYSICIAN FELT A LITTLE RESISTANCE. THE LESION WAS DILATED AND THE BALLOON WAS COMPLETELY INFLATED AT 14ATMS ON FIRST INFLATION. THE BALLOON WAS THEN UNABLE TO DEFLATE. THE PHYSICIAN ATTEMPTED TO PUSH AND PULL THE BALLOON, BUT IT STILL WAS UNABLE TO DEFLATE. THE BALLOON REMAINED INFLATED FOR 1 HOUR. THE PHYSICIAN ADVANCED A 2.5MM UNSPECIFIED BALLOON TO THE LESION AND THE BALLOON WAS INFLATED NEXT TO THE APEX BALLOON. THE INFLATED APEX BALLOON WAS THEN ABLE TO BE REMOVED FROM THE PT INTACT. IT WAS NOTED BY THE PHYSICIAN THAT NO KINKS WERE FOUND ON THE APEX BALLOON AND THE DEVICE WAS ABLE TO INFLATE AND DEFLATE OUTSIDE THE PT'S BODY. THE PROCEDURE WAS COMPLETED WITH THE 2.5MM UNSPECIFIED BALLOON. NO PT COMPLICATIONS WERE REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "GOOD". THIS PRODUCT IS ONLY OUS APPROVED BUT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX PUSH MONORAIL NA LOX BOSTON SCIENTIFIC 1.5X8MM 11337769

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention