BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1133734 · Received August 20, 2008

    Report

    Report Number
    2134265-2008-02391
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 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

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF BY THE USER FACILITY; 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 INFO 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 99% STENOTIC AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE SEVERELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE 3.0MM X 30MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION AND REPORTED TO HAVE BURST AT 12 ATMS WHEN INFLATED FOR 5 SECONDS. IT IS UNK HOW MANY TIMES OR ON WHICH INFLATION THE RUPTURE OCCURRED. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MFR'S DEVICE. NO PT INJURY OR COMPLICATIONS WERE REPORTED. THE PT'S CONDITION WAS REPORTED AS "NO PROBLEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETER, TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS LOX BOSTON SCIENTIFIC 30X3.0 MM 8625752

    Patients

    Seq Age Sex Outcome Treatment
    1