BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²?

    MDR report key: 3120068 · Received May 20, 2013

    Report

    Report Number
    2134265-2013-03208
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MFR: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND A LARGE BUILD-UP OF SOLIDIFIED BLOOD INSIDE THE INFLATION LUMEN AND INSIDE THE BALLOON. THIS BUILD-UP OF BLOOD IS CONSISTENT WITH A LEAK HAVING OCCURRED SOMEWHERE ALONG THE DEVICE. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL COULD NOT IDENTIFY ANY TEARS OR HOLES IN THE BALLOON MATERIAL. ATTEMPTS TO INFLATE THE BALLOON FAILED. THE DEVICE WAS IMMERSED IN WARM WATER FOR 24 HOURS IN AN ATTEMPT TO DISSOLVE THE SOLIDIFIED BLOOD INSIDE THE DEVICE. HOWEVER, ALL ADDITIONAL ATTEMPTS TO INFLATE LIQUID INTO THE BALLOON FAILED. IT WAS NOTED THAT SOME OF THE BLOOD HAD DISSOLVED INSIDE THE BALLOON AND WHEN THE BALLOON WAS COMPRESSED, NO LEAK OF BLOOD WAS NOTED OUT FROM THE BALLOON. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR CORONARY ARTERY. A 15MM X 2.0MM MAVERICK² BALLOON CATHETER WAS USED AND ADVANCED TO THE TARGET LESION. HOWEVER, THE BALLOON RUPTURED AT AN UNKNOWN INFLATION PRESSURE AND AT AN UNKNOWN NUMBER OF INFLATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR CORONARY ARTERY. A 15MM X 2.0MM MAVERICK2 BALLOON CATHETER WAS USED AND ADVANCED TO THE TARGET LESION. HOWEVER, THE BALLOON RUPTURED AT AN UNKNOWN INFLATION PRESSURE AND AT AN UNKNOWN NUMBER OF INFLATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222213 MAVERICK²? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892815200 14989022

    Patients

    Seq Age Sex Outcome Treatment
    1