BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1190617 · Received October 6, 2008

    Report

    Report Number
    2134265-2008-02912
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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 EVAL; 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 SEVERELY CALCIFIED 80% STENOTIC LESION WAS LOCATED IN THE PROXIMAL SEGMENT OF THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 8MM X 3.0MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION FOR POST DILATION OF ANOTHER MFR'S STENT AND REPORTED TO HAVE BURST WHEN INFLATED TO 20 ATMS. IT IS UNK HOW MANY TIMES THE BALLOON WAS INFLATED OR UPON WHICH INFLATION THE EVENT OCCURRED. THE BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT INJURY OR COMPLICATIONS WERE REPORTED. THE PT'S CONDITION WAS REPORTED AS "STABLE".

    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 8X3.0 MM 9238056

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR FIREBIRD 3.0 X 18MM STENT