BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MONORAIL BALLOON CATHETER

    MDR report key: 1002077 · Received February 20, 2008

    Report

    Report Number
    2134265-2008-00503
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOTIC LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED DISTAL LEFT CIRCUMFLEX (LCX). THE 15X3.5MM QUANTUM MAVERICK BALLOON WAS USED TO POST-DILATE A PREVIOUSLY PLACED STENT. HOWEVER, WHEN ATTEMPTING TO WITHDRAW THE BALLOON CATHETER, THE CATHETER BECAME STUCK ON A NON BSC GUIDE WIRE. THE PHYSICIAN SUCCESSFULLY REMOVED THE CATHETER AND GUIDE WIRE AS A UNIT TO COMPLETE THE PROCEDURE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS LISTED AS "GOOD."

    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 15X3.5MM 9120427

    Patients

    Seq Age Sex Outcome Treatment
    1 BMW GUIDE WIRE