BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 2221222 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03563
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND A BUILD UP OF SOLIDIFIED CONTRAST MEDIA INSIDE THE INFLATION LUMEN. SEVERAL ATTEMPTS WERE MADE TO INFLATE THE BALLOON WITHOUT SUCCESS. THE DEVICE WAS IMMERSED IN WARM WATER IN AN ATTEMPT TO DISSOLVE THE SOLIDIFIED CONTRAST MEDIA, HOWEVER ALL ADDITIONAL ATTEMPTS TO INFLATE THE BALLOON FAILED. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL COULD NOT IDENTIFY ANY TEARS OR PINHOLES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON PINHOLE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE NON CALCIFIED RIGHT CORONARY ARTERY (RCA). THE 2.5X20MM APEX MR BALLOON WAS ADVANCED TO PRE-DILATE THE RCA. THE BALLOON WAS INFLATED AND IT WAS NOTED THAT DYE WAS LEAKING OUT, UPON REMOVAL A PIN HOLE WAS NOTED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5X20MM APEX BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON PINHOLE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE NON CALCIFIED RIGHT CORONARY ARTERY (RCA). THE 2.5X20MM APEX MR BALLOON WAS ADVANCED TO PRE-DILATE THE RCA. THE BALLOON WAS INFLATED AND IT WAS NOTED THAT DYE WAS LEAKING OUT, UPON REMOVAL A PIN HOLE WAS NOTED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5X20MM APEX BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895920250 14464930

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR