BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1193280 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02927
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL, AS THE DEVICE WAS DISPOSED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH NUMBER FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATION. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT, DUE TO ANATOMICAL / PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, WHICH LIMITED THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION LOCATION WAS UNK. THE TORTUOSITY OF THE VESSEL WAS UNK, AND THE LEVEL OF CALCIFICATION AND % STENOSIS WERE ALSO UNK. THE MAVERICK2 20 MM X 1.5 MM BALLOON CATHETER WAS ADVANCED TO THE LESION. HOWEVER, UPON INFLATION, THE BALLOON RUPTURED AT 12 ATMS AFTER 10 SECONDS. THE NUMBER OF INFLATIONS IS UNK. THE BALLOON WAS REMOVED INTACT FROM THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    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 20 / 1.5 7995279

    Patients

    Seq Age Sex Outcome Treatment
    1