BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSUREFAST CATHETER, 7F, 60CM

    MDR report key: 2910634 · Received December 4, 2012

    Report

    Report Number
    2953189-2012-00366
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH CLOSUREFAST CATHETER, 7F, 60CM. THE CUSTOMER STATES THAT A PATIENT WAS TREATED FOR A CLOSUREFAST PROCEDURE IN THE (B)(4). AT THE END OF THE TREATMENT OF THE LAST VEIN SEGMENT, THE PHYSICIAN NOTICED THAT THE CATHETER TIP MELTED. THE PROCEDURE WAS A SUCCESS AND THE VEIN CLOSED. THERE WAS NO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSUREFAST CATHETER, 7F, 60CM CLOSUREFAST CATHETER, 7F, 60CM GEI COVIDIEN CF7-7-60 551221

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN