BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1242897 · Received November 19, 2008

    Report

    Report Number
    2134265-2008-04374
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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 PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN WAS POST DILATING AN UNSPECIFIED STENT WITH THE QUANTUM MAVERICK 4.5X12MM. THE BALLOON RUPTURED AT 20 ATM ON THE SECOND INFLATION. THE FIRST INFLATION WAS TO 12 ATM. THE DURATION OF THE INFLATIONS IS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT STATUS POST PROCEDURE WAS GOOD.

    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 CORPORATION 12X4.5 MM 11014831

    Patients

    Seq Age Sex Outcome Treatment
    1