BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK 2 (TM)

    MDR report key: 2223566 · Received August 25, 2011

    Report

    Report Number
    2134265-2011-03492
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON COULD NOT IDENTIFY ANY TEARS OR PINHOLES IN THE BALLOON MATERIAL. THE BALLOON WAS INFLATED, USING AN ENCORE INFLATION DEVICE, TO ITS RATED BURST PRESSURE OF 14 ATMOSPHERES WITH NO LEAKS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED AS THE RETURNED DEVICE REVIEW SHOWED NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR # 2134265-2011-03493. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 80% STENOSED LESION BEING TREATED WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED A RUNWAY GUIDE CATHETER AND A NON-BSC GUIDE WIRE. HE THEN ADVANCED A 2.5X20MM MAVERICK BALLOON CATHETER TO THE TARGET LESION. USING A NON-BSC INFLATOR, THE BALLOON REACHED 10ATMS AND RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND ANOTHER 2.50X20MM MAVERICK BALLOON WAS INFLATED IN THE LESION. A 3.5X28MM LIBERTE STENT WAS THEN IMPLANTED IN THE LESION. THE PHYSICIAN EXCHANGED THE GUIDE CATHETER AND A 3.0X20MM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION; HOWEVER, USING A NON-BSC INFLATOR, THE BALLOON REACHED 12ATMS AND RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THEN A 3.0X20MM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED. TWO LIBERTE STENTS, SIZES 3.50X20MM AND 3.50X28MM, WERE SUCCESSFULLY IMPLANTED IN THE LESION TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR # 2134265-2011-03493. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 80% STENOSED LESION BEING TREATED WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED A RUNWAY GUIDE CATHETER AND A NON-BSC GUIDE WIRE. HE THEN ADVANCED A 2.5X20MM MAVERICK BALLOON CATHETER TO THE TARGET LESION. USING A NON-BSC INFLATOR, THE BALLOON REACHED 10ATMS AND RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND ANOTHER 2.50X20MM MAVERICK BALLOON WAS INFLATED IN THE LESION. A 3.5X28MM LIBERTE STENT WAS THEN IMPLANTED IN THE LESION. THE PHYSICIAN EXCHANGED THE GUIDE CATHETER AND A 3.0X20MM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION; HOWEVER, USING A NON-BSC INFLATOR, THE BALLOON REACHED 12ATMS AND RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THEN A 3.0X20MM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED. TWO LIBERTE STENTS, SIZES 3.50X20MM AND 3.50X28MM, WERE SUCCESSFULLY IMPLANTED IN THE LESION TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK 2 (TM) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892820300 0012162883

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR GUIDE WIRE: CORDIS 0.014 WIZDOM WIRE| GUIDE CATHETER: JR 3.5 6 FR