BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1081516 · Received July 25, 2008

    Report

    Report Number
    2134265-2008-02105
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AT THE USER FACILITY, AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE ANATOMY LOCATION AND VESSEL CHARACTERISTICS OF THE CALCIFIED LESION IS UNKNOWN. THE 8 X 2.5MM QUANTUM MAVERICK MONORAIL CATHETER WAS ADVANCED TO THE LESION AND REPORTED TO HAVE RUPTURED AT 12 ATMS. THE DURATION AND UPON WHICH INFLATION THE EVENT OCCURRED IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS "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 8X2.5 MM 9597048

    Patients

    Seq Age Sex Outcome Treatment
    1