BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2801504 · Received October 23, 2012

    Report

    Report Number
    2134265-2012-06538
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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

    SAME AS MDR ID 2134265-2012-06256. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, POSITIONING PROBLEMS WITH THE DEVICE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THREE ION STENTS WERE IMPLANTED IN THE MIDDLE TO PROXIMAL REGION OF THE RIGHT CORONARY ARTERY. THE LAST STENT IMPLANTED WAS AN ION MR 24MM X 2.75MM STENT THAT WAS DEPLOYED AT 16 ATM. A NC QUANTUM APEX MR 20MM X 3.00MM BALLOON CATHETER ADVANCED PARTIALLY INTO THE FIRST IMPLANTED STENT TO PERFORM POST DILATION AND THE BALLOON CATHETER JUMPED FORWARD OSTIUM THROUGH THE SECOND ION STENT AND HIT THE THIRD 24MM X 2.75MM ION STENT CAUSING STENT DAMAGE. POST DILATION WAS PERFORMED ON ALL THREE ION STENTS WITH THE SAME NC QUANTUM APEX BALLOON CATHETER. A 2.75X12 ION STENT WAS DEPLOYED AT 16 ATM TO COVER THE DAMAGED ION MR 24MM X 2.75MM STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    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 H7493912420300

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR