BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSUREFAST CATHETER, 7F, 100CM

    MDR report key: 2963064 · Received January 25, 2013

    Report

    Report Number
    2953189-2013-00012
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    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)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH CLOSUREFAST CATHETER, 7F, 100CM. THE CUSTOMER STATES THAT TORTUOUS ANATOMY WAS ENCOUNTERED AFTER INSERTION OF THE CATHETER THROUGH THE SHEATH. A GUIDEWIRE WAS REQUIRED IN ORDER FOR THE PHYSICIAN TO NAVIGATE IN THE GSV OF THE LOWER THIGH. THE PHYSICIANS FIRST ATTEMPT TO INSERT A .025 GUIDEWIRE (A COVIDIEN PRODUCT), INTO THE BACK OF THE CATHETER HANDLE WAS UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TWICE TO INSERT A .014 GUIDEWIRE (NOT COVIDIEN PRODUCT), INTO THE BACK OF THE CATHETER HANDLE ALSO WITHOUT SUCCESS. ALL 3 OF THE GUIDEWIRES UTILIZED, FAILED TO ENTER THE CATHETER THOUGH THE HANDLE, AS IT APPEARS THERE WAS A BLOCKAGE IN THE HANDLE OF THE CATHETER. A FOURTH .014 GUIDEWIRE WAS THEN ATTEMPTED TO BE UTILIZED (NOT COVIDIEN PRODUCT), AND WAS ABLE TO BE INSERTED SUCCESSFULLY AND AFTER BEING USED IN COMBINATION WITH A INSERTION TOOL. PRIOR TO THE INSERTION OF THE FOURTH GUIDEWIRE, AND PRIOR TO ADVANCEMENT OF THE CATHETER A THROMBUS WAS IDENTIFIED. THE THROMBUS WAS LOCATED IN THE GSV, YET BEYOND THE CATHETER AND THE TORTUOUS ANATOMY. UPON DISCOVERY OF THE THROMBUS, THE PHYSICIAN DECIDED TO ABORT THE CASE. THERE WAS NO PT INJURY OR HARM NOTED AS A RESULT. THE PHYSICIAN THEN DISCHARGED THE PT WITH NO FURTHER INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36282 CLOSUREFAST CATHETER, 7F, 100CM CLOSUREFAST CATHETER, 7F, 100CM GEI COVIDIEN CF7-7-100 551459

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK