BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1052099 · Received May 21, 2008

    Report

    Report Number
    2134265-2008-01469
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    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, DE NOVO AND ECCENTRIC LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS 45 DEGREE BEND BIFURCATION OF THE LEFT ANTERIOR DESCENDING (LAD) AND DIAGONAL ARTERY. THE LESION WAS REPORTED TO BE 3.5MM X 20MM AND WAS NOT PRE-DILATED. THE PHYSICIAN ADVANCED TWO QUANTUM MAVERICK MR 15MM X 2.75MM BALLOON CATHETER VIA RADIAL ARTERY VASCULAR ACCESS. WHILE ATTEMPTING TO REACH THE TARGET LESION, IT WAS REPORTED THAT THE PHYSICIAN USED EXTRA FORCE, DUE TO SEVERE DIFFICULTY EXPERIENCED DURING INSERTION AND ADVANCEMENT AND THE SHAFT OF ONE QUANTUM MAVERICK MR 15MM X 2.75MM BALLOON CATHETER BROKE. THE SPECIFIC LOCATION OF THE SHAFT BREAK IS UNKNOWN. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "STABLE."

    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 15X2.75 MM 11461747

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 6F GUIDE CATHETER