BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM (TM) MAVERICK (TM)

    MDR report key: 2213135 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03724
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. AN EXAMINATION OF THE RETURNED DEVICE FOUND THAT THERE WAS A LONGITUDINAL SCRATCH IN THE OUTER SHAFT. THE SCRATCH INTERSECTS A TEAR IN THE SHAFT LOCATED 3.7-3.8 CM FROM THE PROXIMAL BALLOON BOND. THE SCRATCH EXTENDS FROM 1.7-4.3 CM FROM THE PROXIMAL BALLOON BOND. THE BALLOON APPEARED TO BE LOOSELY FOLDED WHICH COULD BE EVIDENCE THAT THE SHAFT BURST WHEN THE DEVICE WAS INFLATED AFTER THE SCRATCH WEAKENED THE OUTER SHAFT MATERIAL. THE SHAFT DAMAGE CONFIRMED THE REPORTED 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED WITH A 2.5X20MM MAVERICK BALLOON CATHETER AND A 3.0X2.0MM PROMUS ELEMENT STENT WAS SUCCESSFULLY IMPLANTED. THIS 3.0X12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR POST-DILATION AND WAS ADVANCED TO THE LESION. ON THE FIRST INFLATION, "CONTRAST WAS LEAKING FROM THE QUANTUM LINE" AND THE BALLOON RUPTURED AT 18 ATMS AFTER BEING INFLATED FOR 3 SECONDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED WITH A 2.5X20MM MAVERICK BALLOON CATHETER AND A 3.0X2.0MM PROMUS ELEMENT STENT WAS SUCCESSFULLY IMPLANTED. THIS 3.0X12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR POST-DILATION AND WAS ADVANCED TO THE LESION. ON THE FIRST INFLATION, "CONTRAST WAS LEAKING FROM THE QUANTUM LINE" AND THE BALLOON RUPTURED AT 18 ATMS AFTER BEING INFLATED FOR 3 SECONDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM (TM) MAVERICK (TM) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808012300 13645619

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR STENT DELIVERY SYSTEM: PROMUS ELEMENT 3.0X20MM| BALLOON CATHETER: MAVERICK 2.5X20MM