BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICKS2 MONORAIL PTCA CATHETER

    MDR report key: 1102124 · Received August 7, 2008

    Report

    Report Number
    2134265-2008-02244
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    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

    DEVICE EVALUATION: THE COMPLAINANT INDICATED THAT THE DEVICE 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 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 (PCI) PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE MILDLY CALCIFIED AND AVERAGE TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 1.50X20MM MAVERICK2 BALLOON CATHETER TO THE LESION AND ON THE FIRST INFLATION, INFLATED THE BALLOON TO 10ATMS AND IT RUPTURED. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER BALLOON CATHETER. PATIENT STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICKS2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC MAVERICK2 20/ 1.5 0009712466

    Patients

    Seq Age Sex Outcome Treatment
    1 MACH1 GUIDE CATHETER