BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY CATHETER

    MDR report key: 2954045 · Received November 26, 2007

    Report

    Report Number
    2032474-2007-00002
    Event Type
    Injury
    Date Received
    November 26, 2007
    Date of Event
    October 31, 2007
    Report Date
    November 17, 2007
    Manufacturer
    ALSIUS CORP.
    Product Code
    NCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS MADE BASED UPON THE RECEIPT OF A COMPLAINT. WE ARE ATTEMPTING TO OBTAIN RETURN OF THE CATHETER. THERE IS NOTHING IN THE HISTORY SO FAR THAT INDICATES A DEVICE FAILURE OF USER ERROR. THIS IS AN INITIAL REPORT. WE WILL CORRECT THE REPORT WITH THE PT OUTCOME AND ANY ANALYSIS OF RETURNED PRODUCT SHOULD THIS OCCUR. THE RATE OF REPORT TO ALSIUS OF DVT IS (B)(4). DVT WITH PULMONARY EMBOLUS ARE A KNOWN COMPLICATION OF CENTRAL VENOUS LINE USE. IT IS NOT UNEXPECTED TO SEE PERICATHETER SLEEVE FORMATION AND THROMBUS ON SHORT-TERM HEMODIALYSIS CATHETERS IN THE CENTRAL VEINS [1]. DIRECT VENOGRAPHY OF SUCH CATHETERS, AFTER RELATIVELY SHORT AVERAGE IN-DWELL DURATION OF 21 DAYS, SHOWS RATES OF SLEEVES AND THROMBUS OF GREATER THAN THROMBOSIS AS DETECTED BY ULTRASONOGRAPHY WITH COLOR DOPPLER IMAGING PERFORMED TWICE WEEKLY IN THEIR MEDICAL ICU. DEEP VENOUS THROMBOSIS WAS DETECTED IN (B)(4) ((B)() CONFIDENCE INTERVAL, (B)(4)) OF (B)(4) ELIGIBLE PTS DURING THE 8-MONTH STUDY PERIOD DESPITE PROPHYLAXIS IN (B)(4) OF PTS. OGUZKURT L, TERCAN F, TORUN D, YILDIRIM T, ZUMRUTDAL A, KIZILKILIC O IMPACT OF SHORT-TERM HEMODIALYSIS CATHETERS ON THE CENTRAL VEINS: A CATHETER VENOGRAPHIC STUDY. EUR J RADIOL. 2004 (B)(6); 52 (3): 293-9. HIRSCH DR, INGENTIO EP, GOLDHABER SZ. PREVALENCE OF DEEP VENOUS THROMBOSIS AMONG PTS IN MEDICAL INTENSIVE CARE. JAMA. 1995 (B)(6); 274 (4): 335-7.

    Description of Event or Problem · 1

    THE PT PRESENTED WITH DRUG INDUCED ASYSTOLE AND WAS RESUSCITATED. AFTER RESUSCITATION THE PT WAS COMATOSE. THE CATHETER WAS INSERTED FEMORALLY AND USED TO INDUCED HYPOTHERMIA. THE PT BECAME SHORT OF BREATH. CT DETECTED A PULMONARY EMBOLUS 2.5 DAYS AFTER INSERTION. THE CATHETER WAS REMOVED AFTER DOPPLER DETECTED A DVT IN CALF OF THE SAME LEG AS THE CATHETER. HE RECEIVED AS HEPARIN DRIP AND WILL GET 6 MONTHS OF COUMADIN. THE PT IS DOING "FAIRLY WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY CATHETER HEAT EXCAHNGE CATHETER NCX ALSIUS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other