BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 507415 · Received January 14, 2004

    Report

    Report Number
    6000002-2004-00007
    Event Type
    Other
    Date Received
    January 14, 2004
    Date of Event
    December 11, 2003
    Report Date
    December 15, 2003
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY WHILE USING AN EMBOLECTOMY CATHETER DOWN THE ARTERIAL LIMB AND INTO THE BRACHIAL ARTERY, THE BALLOON GOT STUCK AND WOULD NOT DEFLATE AT THE ANASTAMOSIS, SO THE CATHETER WAS CUT. THEN THE CATHETER WAS PULLED OUT FORCEFULLY AND WHEN IT WAS OUT, NOTICED THAT THE BALLOON WAS GONE WITH ONLY SOME STRINGY FISHING LINE TRAILING OFF THE END OF THE CATHETER. THE BLOOD COMING OUT OF THE GRAFT WAS STRAINED, HOWEVER, NO BALLOON WAS FOUND. NO PERMANENT PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES 120804F UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention