BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX PUSH MONORAIL

    MDR report key: 1172198 · Received September 18, 2008

    Report

    Report Number
    2134265-2008-02706
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 80% STENOTIC DE NOVO 12MM LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL FIRST DIAGONAL ARTERY. THE PHYSICIAN ADVANCED THE 1.5X15MM APEX BALLOON CATHETER TO THE LESION THROUGH SIGNIFICANT RESISTANCE. ON THE FIRST INFLATION, THE PHYSICIAN INFLATED THE BALLOON TO 8ATMS AND A "LOSS OF PRESSURE AT THE MANOMETER AND EXIT OF CONTRAST MEDIA AT THE CORONARY ARTERY WAS OBSERVED." THERE WERE NO PT COMPLICATIONS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 1.5X20MM BALLOON CATHETER. PT STATUS IS REPORTED AS "STABLE." THIS DEVICE IS ONLY OUS APPROVED, BUT IS SIMILAR TO MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX PUSH MONORAIL NA LOX BOSTON SCIENTIFIC 1.5X15 MM 11673842

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR PL 35 TP GUIDE CATHETER| GUIDANT INFLATION DEVICE| BMW 0.14 GUIDEWIRE| 7FR ANOW INTRODUCER SHEATH