BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1133643 · Received August 20, 2008

    Report

    Report Number
    2134265-2008-02402
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Report Date
    August 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE CALCIFIED LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN WAS PREDILATING THE LESION AND INFLATED AN APEX MONORAIL 2.0X12MM BALLOON CATHETER TO 13BAR AND IT BURST AFTER FIRST INFLATION. THE APEX MONORAIL BALLOON CATHETER WAS REMOVED INTACT AND NO STENT WAS DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A QUANTUM MAVERICK BALLOON. PATIENT STATUS AFTER PROCEDURE IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL NA LOX BOSTON SCIENTIFIC CORPORATION 2.0X12 MM 11598742

    Patients

    Seq Age Sex Outcome Treatment
    1