BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 840668 · Received February 16, 2007

    Report

    Report Number
    6000093-2007-00366
    Event Type
    Malfunction
    Date Received
    February 16, 2007
    Date of Event
    January 19, 2007
    Report Date
    January 19, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME EVENT AS MFR# 2954755-2007-00020. IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE MAVERICK2 MONORAIL BALLOON RUPTURED. THE LESION BEING TREATED WAS LOCATED IN THE HEAVILY CALCIFIED, 95% STENOSED SAPHENOUS VEIN GRAFT (SVG). THE PHYSICIAN DEPLOYED A FILTER WIRE DISTAL TO THE LESION AND PREDILATED WITH THE MAVERICK2 MONORAIL BALLOON. ON THE INITIAL INFLATION, THE BALLOON RUPTURED. WHEN THE PHYSICIAN WAS REMOVING THE MAVERICK2 MONORAIL BALLOON CATHETER, HE NOTICED THAT THE DISTAL HALF OF THE BALLOON WAS NOT PRESENT. THE PHYSICIAN USED A 2.0 MAVERICK MONORAIL TO PUSH THE CATHETER TIP AND BALLOON MATERIAL ONTO THE WIRE. WHEN ATTEMPTING TO RECAPTURE THE FILTERWIRE, THE RETRIEVAL SHEATH WAS NOT ABLE TO REACH THE FILTER BECAUSE IT MET RESISTANCE WHERE THE BALLOON MATERIAL REMAINED ON THE WIRE. THE FILTERWIRE AND GUIDE CATHETER WERE REMOVED AS ONE UNIT. WHEN INSPECTING THE FILTERWIRE, THE SHAFT AND BALLOON MATERIAL WERE ON THE FILTER WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER MFR'S GUIDEWIRE AND STENT. IT WAS THE PHYSICIAN'S OPINION THAT THE CALCIFICATION OF THE LESION CAUSED THE BALLOON TO RUPTURE. THE BALLOON WAS THEN HUNG UP ON THE CALCIFICATION CAUSING IT TO RIP. THERE WERE NO FURTHER PT COMPLICATIONS. PT STATUS IS LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOU LOX BOSTON SCIENTIFIC MAVERICK2 12/3.5 9046365

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GUIDEWIRE: .014 COUGAR| STENT: RACER 6.0X18