BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLOSUREFAST CATHETER, 7F, 60CM

    MDR report key: 1982432 · Received February 2, 2011

    Report

    Report Number
    2953189-2011-00009
    Event Type
    Other
    Date Received
    February 2, 2011
    Date of Event
    September 10, 2010
    Report Date
    January 26, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH AN ELECTROSURGICAL DEVICE. THE CUSTOMER REPORTS THAT THE PATIENT CONTINUED TO THROMBUS DURING CATHETER ADVANCEMENT. CATHETER WAS ADVANCED BUT NEVER TURNED ON. THE SAPHENOUS VEIN CONTINUED TO THROMBUS UP TO THE SFJ. THE EPIGASTRIC VEIN REMAINED OPEN. WATCH UNDER ULTRASOUND. AS THE CATHETER WAS ADVANCED, THE PATIENT CONTINUOUSLY THROMBOSED. AT THIS POINT, THE PROCEDURE WAS ABORTED. PATIENT WAS GIVEN ARIXTRA (7.5MG). PATIENT WAS TAKEN BY AMBULANCE TO THE HOSPITAL AND SPENT THE NIGHT IN THE ICU. THE SAPHENOUS VEIN ULTIMATELY OCCLUDED. THE DOCTORS WERE ABLE WITH ANTI COAGULATION THERAPY TO REGRESS THE THROMBUS OUT OF THE COMMON FEMORAL. PATIENT MAY HAVE HAD A UNDIAGNOSED CLOTTING DISORDER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other