BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1052504 · Received May 22, 2008

    Report

    Report Number
    2134265-2008-01497
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, DIFFICULTIES WERE ENCOUNTERED DURING ADVANCING THE BALLOON. THE 99% STENOSED LESION WAS CALCIFIED WITH NO TORTUOSITY IN THE POPLITEAL ARTERY. AS THE 8X3.5MM QUANTUM MAVERICK MR BALLOON CATHETER WAS TRAVELING TOWARD A NON BSC STENT TO POST DILATE, IT GOT STUCK ON A NON BSC WIRE AND THE CATHETER BROKE. THE BALLOON NEVER MADE IT ALL THE WAY TO THE STENT TO INFLATE. THE PHYSICIAN PULLED EVERYTHING OUT AND USED A NEW WIRE AND A NON BSC BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT STATUS IS LISTED AS OK WITH NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION 8X3.5MM 11609772

    Patients

    Seq Age Sex Outcome Treatment
    1 PILOT GUIDEWIRE| CYPHER STENT