BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1063741 · Received June 18, 2008

    Report

    Report Number
    2134265-2008-01721
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    April 27, 2008
    Report Date
    May 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: 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 SUPPLEMENTAL MEDWATCH WILL BE FILLED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 70% STENOTIC LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED MID DIAGONAL ARTERY. THE PHYSICIAN ADVANCED THE 2.0X20MM MAVERICK2 BALLOON TO THE LESION AND ON THE FIRST INFLATION, INFLATED THE BALLOON TO 12ATMS FOR FIFTEEN SECONDS AND THE BALLOON RUPTURED. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 2.0X20MM MAVERICK2 BALLOON. PATIENT STATUS IS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC MAVERICK2 20/2.0 0011132800

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR