BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 3033602 · Received April 3, 2013

    Report

    Report Number
    2134265-2013-01992
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE EVALUATED BY MANUFACTURER, EVALUATION SUMMARY ATTACHED, METHOD CODE, RESULT CODE, CONCLUSION CODE. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND THE INNER SHAFT WAS FOLDED 28MM PROXIMALLY FROM THE PROXIMAL BALLOON BOND. THERE WAS NO OTHER DAMAGE. THE INNER DIAMETER OF THE INNER SHAFT WAS MEASURED AND WAS WITHIN SPECIFICATION. FUNCTIONAL TESTING WAS PERFORMED BY LOADING A .014" GUIDEWIRE INTO THE TIP AND ADVANCING THROUGH THE INNER SHAFT OF THE CATHETER ENCOUNTERING RESISTANCE. THE GUIDEWIRE WOULD NOT ADVANCE PAST THE LOCATION OF THE INNER SHAFT DAMAGE. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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).

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136044 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408250 14221961

    Patients

    Seq Age Sex Outcome Treatment
    1 ATHLETE PREMIUM 0.014INCH: GUIDE WIRE