BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MONORAIL BALLOON CATHETER

    MDR report key: 1022476 · Received March 31, 2008

    Report

    Report Number
    2134265-2008-00925
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 9, 2008
    Report Date
    March 10, 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 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 INTERVENTIONAL (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE CALCIFIED AND EXTREMELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE 8 MM X 4.0 MM QUANTUM MAVERICK MONORAIL BALLOON CATHETER WAS BEING USED TO POST DILATE A 3.5 MM X 24 MM TAXIS DRUG ELUTING STENT WHEN THE BALLOON RUPTURED AT 15 ATMS ON THE INITIAL INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. NO PT COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MONORAIL BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 8 X 4.0 MM

    Patients

    Seq Age Sex Outcome Treatment
    1