BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 3090671 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-03020
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POST DILATATION PROCEDURE, THE CATHETER LOCKED ON THE WIRE. THE TARGET LESION BEING TREATED WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MIDDLE CIRCUMFLEX. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO POST DILATE A PREVIOUSLY DEPLOYED 3.00 X 20MM PROMUS ELEMENT PLUS STENT HOWEVER, THE NON BSC WIRE SEIZED OR "LOCKED" ON THE DEVICE. THE WIRE AND BALLOON WERE REMOVED AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT HAD A SUCCESSFUL COMPLETION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192087 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415300

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR ABBOTT VASCULAR SPORT GUIDE WIRE