BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 823693 · Received February 2, 2007

    Report

    Report Number
    6000093-2007-00249
    Event Type
    Malfunction
    Date Received
    February 2, 2007
    Date of Event
    December 30, 2006
    Report Date
    January 4, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SOURCE CONFIRMED THAT THE PRODUCT HAD BEEN DISPOSED; THEREFORE, DIRECT PRODUCT ANALYSIS CAN BE COMPLETED. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8704971 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE DIFFICULTIES STATED IN THE COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PCI PROCEDURE, THE MAVERICK2 MONORAIL BALLOON RUPTURED. THE LESION BEING TREATED WAS LOCATED IN THE 99% STENOSED AND CALCIFIED RIGHT CORONARY ARTERY (RCA). AT FIRST ATTEMPT THE MAVERICK2 MONORAIL BALLOON WAS UNABLE TO CROSS THE LESION. THE LESION WAS THEN PRE-DILATED WITH A MAVERICK 2.0MM BALLOON. THE MAVERICK 15 X 2.25 WAS THEN REINSERTED AND RUPTURED AT 12 ATMS ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A QUANTUM MAV 2.25 BALLOON. PATIENT STATUS WAS REPORTED AS 'GOOD'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO LOX BOSTON SCIENTIFIC MAVERICK2 15/ 2.25 8704971

    Patients

    Seq Age Sex Outcome Treatment
    1 *