BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²¿

    MDR report key: 3062123 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02362
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER (B)(4). DEVICE RETURNED BY MFR.: IT IS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 12MM X 2.5MM MAVERICK 2 MONORAIL BALLOON CATHETER WAS USED FOR DILATATION OF THE LESION. AN INITIAL AND SECONDARY INFLATION WAS PERFORMED AT 18 ATMS EACH, UPON THE THIRD INFLATION THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT POST PROCEDURE WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162865 MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892812250 0015701685

    Patients

    Seq Age Sex Outcome Treatment
    1