BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRALITE FLOW DIRECTED CATHETER

    MDR report key: 36157 · Received August 26, 1996

    Report

    Report Number
    2951420-1996-00006
    Event Type
    Other
    Date Received
    August 26, 1996
    Date of Event
    August 19, 1996
    Report Date
    August 23, 1996
    Manufacturer
    MEDTRONIC MIS
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO EMBOLIZE AN AVM IN THE POSTERIOR CEREBRAL ARTERY WITH A FLOW DIRECTED MICRO CATHETER. ANOTHER CATHETER WAS FIRST INSERTED THROUGH A GUIDING CATHETER AND DID NOT ADEQUATELY REACH THE PATHOLOGY. THE OTHER CATHETER THEN BECAME LODGED IN THE ARTERY AND REQUIRED 20 MINUTES OF GENTLE TENSION TO REMOVE THE CATHETER FROM THE POSTERIOR CIRCULATION. THE FLOW DIRECTED MICRO CATHETER WAS THEN FLOATED TO THE AVM. ALTHOUGH THE CATHETER REACHED THE AVM, THE PHYSICIAN DID NOT FEEL THAT IT WAS POSITIONED CORRECTLY FOR OPTIMUM EMBOLIZATION. HE THEN ATTEMPTED TO PULL THE DEVICE BACK WHEN IT GOT STUCK IN THE CEREBRAL VESSELS. THE PHYSICIAN THEN INSERTED ANOTHER CO'S WIRE INTO THE DEVICE TO PROVIDE MORE COLUMN STRENGTH TO THE SYSTEM. THE DEVICE STILL COULD NOT BE PULLED OUT OF THE VESSEL. THE PHYSICIAN THEN REMOVED THE GUIDEWIRE AND PULLED ON THE CATHETER UNTIL THE 45 CM DISTAL SECTION STRETCHED TO 100 CM. HE TRIED THE DISTAL SECTION TO THE SHEATH IN THE GROIN, HEPARINIZED THE PT AND THE LEFT THE CATHETER IN THE VESSELS OVERNIGHT. THE NEXT MORNING THE CATHETER HAD RELAXED AND RECOILED TO THE MESENTERIC ARTERY WHERE IT COULD BE REMOVED FROM THE PT. THERE WAS NO EVIDENCE OF PT INJURY OR ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRALITE FLOW DIRECTED CATHETER FLOW DIRECTED MICRO CATHETER DYG MEDTRONIC MIS FD18604 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization