BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALSIUS

    MDR report key: 2445275 · Received February 3, 2012

    Report

    Report Number
    3003793491-2011-00004
    Event Type
    Injury
    Date Received
    February 3, 2012
    Date of Event
    August 5, 2011
    Report Date
    December 13, 2011
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ICY-3 CATHETER DWELL TIME HAD BEEN THREE DAYS. IT WAS REPORTED BY THE REPORTER THAT CARDIAC ARREST NECESSITATED HYPOTHERMIA. IT WAS UNK WHETHER ANY ADJUNCT THERAPY OR TREATMENT ALONG WITH HYPOTHERMIA WAS PERFORMED. IN ADDITION, DVT (PULMONARY EMBOLISM) INTERVENTION IN THE FORM OF HEPARINIZATION WAS ADMINISTERED. NO ADDITION INFO WAS AVAILABLE FROM THE REPORTER. ICY-3 CATHETER PRODUCT LABELING WARNS OF VESSEL WALL PERFORATION AS A POSSIBILITY DURING GUIDEWIRE PASSAGE INTO THE RIGHT HEART. CENTRAL VENOUS CATHETERIZATION SHOULD ONLY BE PERFORMED BY WELL-TRAINED PERSONNEL WELL VERSED IN ANATOMICAL LANDMARKS AND SAFE TECHNIQUE. PERSONNEL SHOULD ALSO HAVE KNOWLEDGE OF POTENTIAL COMPLICATIONS. ("IFU ICY", DOCUMENT NUMBER 103148-001). IT IS POSSIBLE THAT THIS FAILURE (I.E. DISSECTION AND/OR DILACERATION) MIGHT HAVE BEEN CAUSED BY THE OPERATING PHYSICIAN DURING CATHETER PLACEMENT OR REPOSITIONING OF THE CATHETER. VESSEL INJURY IS A COMMON RISK TO ALL INTRAVASCULAR CATHETERS. (B)(4).

    Description of Event or Problem · 1

    A CENTER WHICH EXPERIENCED A PULMONARY EMBOLISM FOLLOWING A 3 DAYS USE OF AN ICY CATHETER. THE VENOUS ECHOGRAPHY SHOWED A "DISSECTION" (THEY CALL IT "DILACERATION") OF THE INTIMA OF THE INFERIOR VENA CAVA (IVC). THEY THINK THAT THERE IS A DIRECT RELATIONSHIP BETWEEN THIS VENOUS LESION AND THE ICY. I HAVE ALREADY SEEN DEEP VENOUS THROMBOSIS (DVT) INDUCED BY ABY CENTRAL VENOUS CATHETER (ICY INCLUDED) BUT NEVER A DIRECT LESION OF THE INNER WALL OF THE IVC FOLLOWING THE INSERTION OF ANY CENTRAL VENOUS CATHETER, AND CERTAINLY NOT OF THE ICY. THE DOCTORS DID NOT KEEP THE CATHETER ONCE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALSIUS ICY CATHETER NCX ZOLL CIRCULATION IC-3893AE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other