BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 607889 · Received May 20, 2005

    Report

    Report Number
    6000089-2005-00719
    Event Type
    Malfunction
    Date Received
    May 20, 2005
    Date of Event
    April 14, 2005
    Report Date
    April 20, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LOX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA TREATMENT PROCEDURE, THE MAVERICK2 30X2.5MM BALLOON RUPTURED AT 12 ATMS ON THE THIRD INFLATION. THE FIRST INFLATION WAS TO 12 ATMS AND THE SECOND INFLATION WAS TO 14 ATMS. THE PATIENT WAS ASYMPTOMATIC DURING THIS EVENT. THE LESION BEING TREATED WAS A 99% STENOTIC LESION IN THE RIGHT CORONARY ARTERY. THEY PHYSICIAN USED A 7F TERUMO LONG INTRODUCER SHEATH FOR VASCULAR ACCESS, A ZUMZ2 FR5SH GUIDE CATHETER AND A GETZ ROUTE GUIDE WIRE FOR VASCULAR ACCESS. IT IS NOTED THAT RESISTANCE WAS MET WHEN THE MAVERICK2 MONORAIL BALLOON WAS REMOVED FROM THE PATIENT. A QUANTUM MAVERICK BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER PTCA CATHETER LOX BOSTON SCIENTIFIC CORP. MAVERICK2-MR 30/2.5MM 7108487

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN