BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MONORAIL BALLOON CATHETER

    MDR report key: 1022288 · Received March 26, 2008

    Report

    Report Number
    2134265-2008-00877
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, A SHAFT BREAK OCCURRED. THE 90% STENOTIC, PROGRESSIVE, DE NOVO LESION WAS LOCATED AT A BIFURCATION OF THE MILDLY CALCIFIED AND SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. VASCULAR ACCESS WAS GAINED VIA THE RADIAL ARTERY. THE 12MM X 3.5MM QUANTUM MAVERICK MONORAIL BALLOON CATHETER WAS BEING USED TO POST DILATE A DRUG ELUTING STENT. ON INFLATION WAS PERFORMED TO 18 ATMS. SIGNIFICANT RESISTANCE WAS REPORTED DURING WITHDRAWAL AND A SHAFT BREAK OCCURRED. IT WAS FURTHER REPORTED THAT THE SHAFT SLIGHTLY KINKED DURING THE PROCEDURE. THE DEVICE WAS REMOVED WITH THE GUIDE CATHETER AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. NO PT COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MONORAIL BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 12X3.5MM 11169959

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR