BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-CROSS CATHETERS

    MDR report key: 1980055 · Received January 24, 2011

    Report

    Report Number
    1980055
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ONGOING CONCERN REGARDING THE NUMBER OF I-CROSS CATHETERS NEEDING TO BE REPLACED OVER THE PAST 12-24 MONTHS. THE CATHETER IS USED IN THE EVALUATION OF INTRAVASCULAR CORONARY VESSELS, AND THERE HAVE BEEN DIFFERENT PROBLEMS WITH THE DEVICE. PROBLEMS INCLUDE (1) THE INABILITY TO VISUALIZE VESSEL INTIMA; (2) A LACK OF ANY IMAGE IF THE CATHETER IS MANIPULATED AND RE-ADVANCED (3) ISSUE WITH A 'FLOPPY' CATHETER, THAT IS, THE SENSE THAT SOMETHING SNAPPED INSIDE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-CROSS CATHETERS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC H749518050 13947364

    Patients

    Seq Age Sex Outcome Treatment
    1 *