BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1180842 · Received September 23, 2008

    Report

    Report Number
    2134265-2008-02763
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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 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 TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE ECCENTRIC 95% STENOTIC AND MODERATELY CALCIFIED LESION WAS LOCATED IN THE PROXIMAL SEGMENT OF THE MILDLY TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. THE LESION WAS PRE-DILATED WITH A 2.5MM X 12 MM MAVERICK BALLOON AND A 2.75MM X 12MM TAXUS STENT WAS DEPLOYED. THE 2.75MM X 8MM QUANTUM MAVERICK MONORAIL BALLOON CATHETER WAS USED TO POST-DILATE THE STENT AND REPORTED TO HAVE BURST AT 10 ATM'S. THE DURATION OF THE INFLATION IS UNKNOWN, NOR HOW MANY TIMES OR ON WHICH INFLATION THE EVENT OCCURRED. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE PATIENT'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 8X2.75 MM 8863221

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR