BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICY CATHETER

    MDR report key: 2923267 · Received August 28, 2006

    Report

    Report Number
    2032474-2006-00001
    Event Type
    Malfunction
    Date Received
    August 28, 2006
    Date of Event
    August 16, 2006
    Report Date
    September 25, 2006
    Manufacturer
    ALSIUS CORP.
    Product Code
    NCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS NOT BEEN RETURNED DESPITE REPEATED ATTEMPTS TO OBTAIN ITS RELEASE FROM THE INSTITUTION IN QUESTION. FROM THE HISTORY AVAILABLE, THE CATHETER WAS USED SUCCESSFULLY UNTIL THE TIME FOR REMOVAL. ON ATTEMPTED REMOVAL OF THE CATHETER, IT CAME OUT EASILY UNTIL JUST PAST THE FIRST SEGMENT OF THE BALLOON. AT THIS POINT IT BECAME "STUCK". THE BAG OF FLUSH WAS CHECKED TO ENSURE THAT NONE HAD LEAKED INTO THE PT. IT WAS STILL FULL I.E. PRIOR TO AN ATTEMPT AT REMOVAL THERE HAD BEEN NO BALLOON LEAK/RUPTURE. THE ATTENDING STAFF DECIDED IT WAS SAFEST TO DO A CUT DOWN ON THE CATHETER TO REMOVE IT. THE CATHETER WAS SUCCESSFULLY REMOVED THROUGH AN INCISION IN THE GROIN. FROM THE HISTORY, IT IS SUGGESTIVE EITHER THAT: THE BALLOONS WERE NOT DRAINED FULLY OF FLUID PRIOR TO EXTRACTION AS PER THE INSTRUCTIONS FOR USE. WITH ATTEMPTED EXTRACTION ONE LODGED IN THE INSERTION CANAL. OR, FOR OTHER REASONS THE CATHETER WAS RETAINED IN THE INSERTION CANAL. IN EITHER CASE, TRACTION APPLIED LED TO RUPTURE OF THE BALLOON AND TO A BUNCHING UP OF THE BALLOON IN THE INSERTION CANAL. ALTHOUGH THIS EVENT DOES NOT CONSTITUTE A SERIOUS INJURY IN ITSELF, IF IT RECURRED IT COULD RESULT IN SERIOUS INJURY UNDER OTHER CIRCUMSTANCES. THE SURGICAL RECOVERY OF THE CATHETER WAS SKILLFUL IN THIS CASE. THIS IS THE FIRST REPORT OF A RETAINED ALSIUS ICY CATHETER. THERE HAVE BEEN OVER 6,000 ALSIUS ICY CATHETERS SHIPPED.

    Description of Event or Problem · 1

    A REPORT FROM UNIV HOSP OF (B)(6) THAT THE ICY CATHETER WAS SURGICALLY REMOVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY CATHETER SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING NCX ALSIUS CORP. IC3585AE 14733

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention CATHETER WAS SUCCESSFULLY REMOVED THROUGH AN| INCISION IN THE GROIN.