BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 2202689 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03439
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY ATTACHED, DEVICE EVALUATED BY MFG, METHOD, RESULT, CONCLUSION UPDATED. LABELED FOR SINGLE USE CORRECTED FROM NO TO YES. THE DEVICE WAS RETURNED. MAGNIFIED INSPECTION REVEALED THE INNER SHAFT WAS BUCKLED NEAR THE DISTAL END OF THE STRAIN RELIEF AND EXTENDING PROXIMALLY INTO THE HUB. THE DAMAGE TO THE INNER SHAFT RESTRICTED A GUIDEWIRE FROM BEING INSERTED AND TRACKED THROUGH THE LUMEN. A THOROUGH INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED NO OTHER DAMAGE OR IRREGULARITIES. 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 2134265-2011-03220. IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE FOREIGN MATERIAL WAS FOUND. THE LESION BEING TREATED WAS LOCATED IN THE CALCIFIED AND TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THEY WERE UNABLE TO EXCHANGE THE CHOICE PT GUIDE WIRE THROUGH THE APEX 2.0X15MM BALLOON AS COATING MATERIAL WAS BLOCKING THE SHAFT OF CATHETER OF THE MANIFOLD. THE CHOICE PT GUIDE WIRE BROKE OFF IN AN EFFORT TO ADVANCE THROUGH THE BALLOON. AT THIS POINT THE BALLOON AND WIRE WERE BOTH REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2011-03220. IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE FOREIGN MATERIAL WAS FOUND. THE LESION BEING TREATED WAS LOCATED IN THE CALCIFIED AND TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THEY WERE UNABLE TO EXCHANGE THE CHOICE PT GUIDE WIRE THROUGH THE APEX 2.0X15MM BALLOON AS COATING MATERIAL WAS BLOCKING THE SHAFT OF CATHETER OF THE MANIFOLD. THE CHOICE PT GUIDE WIRE BROKE OFF IN AN EFFORT TO ADVANCE THROUGH THE BALLOON. AT THIS POINT THE BALLOON AND WIRE WERE BOTH REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895815200 14354098

    Patients

    Seq Age Sex Outcome Treatment
    1 CHOICE PT GUIDE WIRE