BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2222448 · Received August 25, 2011

    Report

    Report Number
    2134265-2011-03556
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 5, 2011
    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

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED FOR ANALYSIS. THERE WAS BLOOD AND CONTRAST IN THE HUB, BALLOON AND DISTAL END OF THE WIRE LUMEN. INSPECTION OF THE BALLOON REVEALED A PINHOLE IN THE BALLOON WALL 5MM FROM THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. THERE WAS ALSO DAMAGE TO THE DISTAL TIP. MAGNIFIED INSPECTION OF THE BALLOON MATERIAL PRESENTED NO INDICATION OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED 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).

    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 CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER TO THE TARGET LESION. ON THE SECOND INFLATION THE BALLOON REACHED 16ATMS AND RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    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 CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER TO THE TARGET LESION. ON THE SECOND INFLATION THE BALLOON REACHED 16ATMS AND RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412250 13814697

    Patients

    Seq Age Sex Outcome Treatment
    1