BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1002094 · Received February 20, 2008

    Report

    Report Number
    2134265-2008-00507
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 8, 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

    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 INFORMATION 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 80% STENOTIC LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 20MM X 2.75MM MAVERICK2 MONORAIL BALLOON CATHETER WAS ADVANCED FOR PREDILATION. THE BALLOON RUPTURED AT 15 ATMS ON THE SECOND INFLATION. THE FIRST INFLATION WAS ALSO PERFORMED TO 15 ATMS. THE PT REMAINED ASYMPTOMATIC DURING THIS EVENT AND THE DEVICE WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PT COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC MAVERICK2 20/2.75 11103542

    Patients

    Seq Age Sex Outcome Treatment
    1 LAUNCHER GUIDE CATHETER| TERUMO INTRODUCTION SHEATH