BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK 2 MONORAIL PTCA CATHETER

    MDR report key: 734080 · Received June 28, 2006

    Report

    Report Number
    6000089-2006-01326
    Event Type
    Malfunction
    Date Received
    June 28, 2006
    Date of Event
    June 5, 2006
    Report Date
    June 5, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Removal / Correction Number
    NA
    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 IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE MAVERICK 2 MONORAIL BALLOON RUPTURED AT 8 ATMS. THE 99% STENOSED LESION WAS LOCATED IN THE TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE GUIDE WIRE CROSSED THE LESION AND THE ATLANTIS SR PRO .2 WAS INSERTED INTO THE DISTAL LEFT ANTERIOR DESCENDING ARTERY, BUT WAS UNABLE TO CROSS AT THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A VOYAGER BALLOON CATHETER WAS CHANGED TO THE RYUJIN AND DILATION OF THE LESION WAS ATTEMPTED. THE RYUJIN WAS ABLE TO CROSS THE LESION WITH STRONG RESISTANCE. THE VOYAGER AND MAVERICK 2 WERE INSERTED A SECOND TIME EACH, BUT REMAINED UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN CHANGED THE GUIDE WIRE FROM HI TORQUE TRECK TO GRAND SLAM AND ATTEMPTED TO CROSS THE LESION WITH THE MAVERICK 2 AGAIN. THE MAVERICK 2 WAS PASSED THROUGH WITH RESISTANCE, BUT IT WAS NOT ABLE TO APPROACH THE APICAL LEFT ANTERIOR DESCENDING ARTERY. THE BALLOON WAS INFLATED TO 6 ATMS. THE PHYSICIAN ATTEMPTED TO INCREASE THE PRESSURE TO 12 ATMS; THE GAUGE OF THE INFLATION DEVICE DECREASED AND IT WAS DETERMINED THAT THE BALLOON WAS RUPTURED. IT WAS CONFIRMED THAT NO CONTRAST MEDIA WAS IN THE BALLOON; IT WAS DEFLATED AND WITHDRAWN FROM THE PATIENT. THE BALLOON RUPTURE WAS VISUALLY CONFIRMED. THE PHYSICIAN INSERTED THE VOYAGER AND IT WAS ABLE TO CROSS WITH RESISTANCE. THE DISTAL AND PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WERE DILATED SEVERAL TIMES AND IVUS IMAGING WAS PERFORMED. TWO CYPHER STENTS WERE DEPLOYED AND IVUS IMAGING WAS PERFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURIES WERE REPORTED AND THE CURRENT PATIENT STATUS IS REPORTED AS "NO PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK 2 MONORAIL PTCA CATHETER PTCA CATHETERS LOX BOSTON SCIENTIFIC MAVERICK2-MR 15 / 0008501158

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN