BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA BALLOON CATHETER

    MDR report key: 718729 · Received May 22, 2006

    Report

    Report Number
    6000089-2006-00996
    Event Type
    Malfunction
    Date Received
    May 22, 2006
    Date of Event
    April 23, 2006
    Report Date
    April 23, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN INTERVENTION FOR INSTANT RESTENOSIS, DEFLATION DIFFICULTIES WERE ENCOUNTERED WITH THE MAVERICK2 MONORAIL 20X2.5MM BALLOON AFTER THE FIRST INFLATION. THE LESION BEING TREATED WAS IN THEMID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE PHYSICIAN USED A 6F INTRODUCER SHEATH FOR VASCULAR ACCESS, A 6F INTRODUCER SHEATH FOR VASCULAR ACCESS, A 6F CLS 3.5 GUIDE CATHETER AND A BMW GUIDE WIRE TO CROSS THE LESION. THE MAVERICK2 MONORAIL BALLOON EVENTUALLY DEFLATED AND WAS REMOVED. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA BALLOON CATHETER PTCA CATHETER LOX BOSTON SCIENTIFIC 20MMX2.5MM 8321284

    Patients

    Seq Age Sex Outcome Treatment
    1 *