BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1081533 · Received July 25, 2008

    Report

    Report Number
    2134265-2008-02089
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 2.0X15 MAVERICK2 MONORAIL BALLOON CATHETER WAS INFLATED FOR 3 SECONDS AND RUPTURED AT 6 ATMOSPHERES ON THE FIRST INFLATION. THE PHYSICIAN USED A CUTTING BALLOON TO OPEN THE VESSEL DUE TO THE TOTAL OCCLUSION TO COMPLETE THE PROCEDURE. THE PT STATUS IS LISTED AS STABLE WITH NO COMPLICATIONS REPORTED.

    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 15 / 2.0 0011672887

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR