BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANUM MAVERICK MONORAIL BALLOON CATHETER

    MDR report key: 1012503 · Received March 12, 2008

    Report

    Report Number
    2134265-2008-00744
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 26, 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 INTERVENTIONAL (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE SEVERELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE QUANTUM MAVERICK 12MM X 3.0MM BALLOON CATHETER WAS ADVANCED AND INFLATED TO 12 ATMS ON THE FIRST INFLATION, HOWEVER, THE BALLOON RUPTURED AT 20 ATMS ON THE SECOND INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANUM MAVERICK MONORAIL BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 12X3.0 MM 11260353

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK BALKIN 6F INTRODUCER SHEATH| 0.035 RADIFOCUS 260CM GUIDE WIRE