BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1063635 · Received June 19, 2008

    Report

    Report Number
    2134265-2008-01727
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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 INTERVENTION, A SHAFT FRACTURE OCCURRED. THE PHYSICIAN ATTEMPTED TO ADVANCE A 3.0X12MM MAVERICK BALLOON TO AN UNSPECIFIED LESION. WHILE THE DEVICE WAS BEING ADVANCED, THE SHAFT BROKE. THE FRACTURED DEVICE WAS ABLE TO BE REMOVED FROM THE PT WITHOUT FURTHER INTERVENTION. NO PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    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 12/3.0 11568081

    Patients

    Seq Age Sex Outcome Treatment
    1