BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2993383 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01724
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: RETURNED DEVICE WAS CONSISTED OF A NC QUANTUM APEX CATHETER WAS RECEIVED INSIDE A CARRIER TUBE (HOOP). MAGNIFIED INSPECTION REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL FROM THE PROXIMAL TO DISTAL END OF THE BALLOON. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. 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 99% STENOSED, SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY. A 3.50 MM X 8 MM NC QUANTUM APEX BALLOON CATHETER WAS USED. THE BALLOON WAS SUCCESSFULLY INFLATED ON THE FIRST ATTEMPT AT AN UNKNOWN PRESSURE. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 10 ATM. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED, SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY. A 3.50MMX8MM NC QUANTUM APEX BALLOON CATHETER WAS USED. THE BALLOON WAS SUCCESSFULLY INFLATED ON THE FIRST ATTEMPT AT AN UNKNOWN PRESSURE. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 10ATM. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96793 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408350 15308888

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR