BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1192126 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02949
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    August 5, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, PRODUCT ANALYSIS WAS NOT POSSIBLE. WITHOUT AN ANALYSIS OF THE COMPLAINT DEVICE IT WAS NOT POSSIBLE TO CONFIRM THE REPORTED DAMAGE AND INSPECT THE DEVICE FOR POSSIBLE ROOT CAUSES. THOUGH THE EXACT CAUSE OF THE REPORTED EVENT WAS NOT DETERMINED, THE MOST PROBABLE ROOT CAUSE IS CONSIDERED OPERATIONAL CONTEXT. THIS IS DUE TO THE LIKELIHOOD THAT THE REPORTED EVENT IS ATTRIBUTABLE TO PROCEDURAL FACTORS AND/OR INTERACTION WITH PT ANATOMY OR OTHER DEVICES. AS THE BATCH NUMBER IS UNKNOWN A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CARRIED OUT.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A DISSECTION OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (MID LAD) ARTERY. DURING POST-DILATATION OF A 2.25 X 12 MM STUDY STENT WITH A QUANTUM MAVERICK BALLOON, A DISSECTION OCCURRED. TWO POST-DILATATIONS WITH MAXIMUM INFLATION PRESSURE OF 18 ATM OCCURRED. A 2.25 X 8 MM BAILOUT STUDY STENT WAS PLACED. THE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECTS. THERE WERE NO REPORTED COMPLICATIONS.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention