BEUDAMED
    FDA Adverse Event Death Summary report: N

    NC QUANTUM APEX BALLOON CATHETER

    MDR report key: 5993637 · Received October 3, 2016

    Report

    Report Number
    2134265-2016-08775
    Event Type
    Death
    Date Received
    October 3, 2016
    Report Date
    September 12, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE USE/USER ERROR AS THE DIRECTION FOR USE STATES: "DO NOT EXCEED THE BALLOON RATED BURST PRESSURE¿ (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645526 NC QUANTUM APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK651

    Patients

    Seq Age Sex Outcome Treatment
    1 Death STENT: MEDTRONIC