BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 3719520 · Received April 1, 2014

    Report

    Report Number
    3003793491-2014-00176
    Event Type
    Injury
    Date Received
    April 1, 2014
    Date of Event
    February 24, 2014
    Report Date
    March 7, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT HYPOTHERMIA THERAPY WAS SUCCESSFULLY COMPLETED PRIOR TO THE DISCOVERY OF THE REPORTED DVT. PER ZOLL LABELING, THROMBOSIS IS A POSSIBLE COMPLICATION WITH CENTRAL VENOUS CATHETERS. IN ADDITION, PHYSICIAN INDICATED THAT THE PATIENT WAS AT AN INCREASED RISK FOR DVT DUE TO IMMOBILIZATION AND INTRACEREBRAL HEMORRHAGE. FURTHERMORE, THERE WERE NO REPORTS OF ANY ISSUES OR DEVICE MALFUNCTIONS RELATED TO THE ZOLL ICY CATHETER. PRODUCT INVOLVED IN THE COMPLAINT WILL NOT BE RETURNED. THEREFORE, PHYSICAL INVESTIGATION CANNOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE FILED IF THE PRODUCT IN COMPLAINT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEEP VEIN THROMBOSIS (DVT) WAS FOUND IN A (B)(6) YEAR OLD, MALE PATIENT, WEIGHING 89 KILOGRAMS AFTER REMOVAL OF THE ZOLL ICY CATHETER. THE PRIMARY CAUSE FOR HOSPITALIZATION ON (B)(6) 2014 WAS DUE TO INTRACEREBRAL HEMORRHAGE. A COOLING BLANKET WAS APPLIED PRIOR TO THE INITIATION OF COOLING. BLOOD COAGULOPATHY RESULTS OBTAINED PRIOR TO APPLYING HYPOTHERMIA INDICATED THAT THE PATIENT HAD NORMAL PLATELETS, PT (PROTHROMBIN TIME) AND INR (INTERNATIONAL NORMALIZED RATIO) VALUES. THE ZOLL ICY CATHETER WAS PLACED IN THE RIGHT FEMORAL VEIN AND HAD AN APPROXIMATE DWELL TIME OF 72 HOURS. INSERTION WAS SMOOTH AND WAS MADE IN ONE ATTEMPT. THERE WERE NO KNOWN CONDITIONS CAUSING THE PATIENT TO BE NON-AMBULATORY PRIOR TO HOSPITALIZATION. HYPOTHERMIA TREATMENT USING THE ZOLL ICY CATHETER WAS SUCCESSFULLY COMPLETED. A LEFT BRACHIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS PLACED PRIOR TO THE DISCOVERY OF THE DVT. PATIENT WAS ON SUBCUTANEOUS HEPARIN FOR DVT PROPHYLAXIS BUT WAS NOT GIVEN ANY FORM ON INTRAVENOUS HEPARIN. A CT SCAN OF THE ABDOMEN WAS PERFORMED ON (B)(6) 2014, A WEEK AFTER THE CATHETER WAS REMOVED BECAUSE THE PATIENT HAD UNEXPLAINED FEVER. AN INCIDENTAL FINDING OF A DVT DUE TO INCREASED FEVER WAS DISCOVERED IN THE RIGHT EXTERNAL ILIAC AND RIGHT COMMON ILIAC. THE INTERVENTIONAL RADIOLOGY (IR) LAB PLACED A FILTER IN THE PATIENT ON (B)(6) 2014 TO MITIGATE THE DVT. THERE WERE NO VESSEL INJURIES CAUSED BY THE ZOLL ICY CATHETER. PATIENT WAS AT AN INCREASED RISK FOR DVT DUE TO IMMOBILIZATION AND INTRACEREBRAL HEMORRHAGE. AS OF (B)(6) 2014, THE PATIENT IS STABLE AND IN REHAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194257 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION, INC 8700-0657-01

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other LEFT BRACHIAL PICC LINE| TYLENOL, BUSPAR X1, WARM BLANKETS| COOLING BLANKET