BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK 2 (TM)

    MDR report key: 2221402 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03526
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: AN INITIAL VISUAL EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED NO TEARS IN THE BALLOON. HOWEVER, WHEN AN ATTEMPT WAS MADE TO INFLATE LIQUID INTO THE BALLOON, A PINHOLE LEAK WAS IDENTIFIED. THE LEAK WAS LOCATED AT APPROXIMATELY 0.5MM DISTAL TO CENTER MARKERBAND. A MICROSCOPIC EXAMINATION OF THE MARKERBAND AND BALLOON MATERIAL COULD NOT IDENTIFY ANY ANOMALIES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE PINHOLE LEAK. 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

    SAME CASE AS MDR # 2134265-2011-03527. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING. THE PHYSICIAN ADVANCED A 15MM X 1.5MM MAVERICK 2 BALLOON CATHETER TO THE TARGET LESION. THE BALLOON REACHED 7ATMS AND RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PHYSICIAN ADVANCED A DIFFERENT 15MM X 1.5MM MAVERICK 2 BALLOON CATHETER TO THE TARGET LESION. THE BALLOON REACHED 12ATMS AND RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER AND TWO UNSPECIFIED STENTS WERE DEPLOYED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING. THE PHYSICIAN ADVANCED A 15MM X 1.5MM MAVERICK 2 BALLOON CATHETER TO THE TARGET LESION. THE BALLOON REACHED 7ATMS AND RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PHYSICIAN ADVANCED A DIFFERENT 15MM X 1.5MM MAVERICK 2 BALLOON CATHETER TO THE TARGET LESION. THE BALLOON REACHED 12ATMS AND RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER AND TWO UNSPECIFIED STENTS WERE DEPLOYED. 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 H7493892815150 14295283

    Patients

    Seq Age Sex Outcome Treatment
    1