BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 3010497 · Received March 19, 2013

    Report

    Report Number
    2134265-2013-01530
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTARY MEDWATCH WILL BE FILED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). THE 8MM X 1.20MM EMERGE BALLOON CATHETER WAS ADVANCED INTO THE LESION. INFLATION WAS PERFORMED TWICE TO 18ATMS. DURING THE THIRD INFLATION, THE BALLOON RUPTURED AT 18ATMS. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114016 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919308120 15709965

    Patients

    Seq Age Sex Outcome Treatment
    1