BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CROSS

    MDR report key: 1121683 · Received August 12, 2008

    Report

    Report Number
    1121683
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    January 16, 2008
    Report Date
    August 5, 2008
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN NOTED THAT THE TIP OF THE QUICK-CROSS SUPPORT CATHETER HAD COME OFF AND ASKED FOR A SNARE TO RETRIEVE IT FROM PATIENT. IT WAS SUCCESSFULLY RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK-CROSS CATHETER, SUPPORT DRB SPECTRANETICS CORPORATION * 0708101

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR